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Guidant Corp.

300 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
VALITUDE™ (Model U125) VALITUDE™ X4 (Model U128) VISIONIST™ (Models U225, U226) VISIONIST™ X4 (Model U228) Firmware Vers (P030005/S250)Guidant Corp.2025-12-19
VALITUDE™ (Model U125); VALITUDE X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST X4 (Model U228) (P030005/S251)Guidant Corp.2025-12-17
U125 VALITUDE™ CRT-P,U128 VALITUDE™ X4 CRT-P,U225 VISIONIST™ CRT-P,U226 VISIONIST™ CRT-P,U228 VISIONIST™ X4 CRT-P (P030005/S249)Guidant Corp.2025-10-22
Accolade Cardiac Resynchronization Therapy Pacemakers, VALITUDE (Model U125); VALITUDE X4 (Model U128); VISIONIST (Model (P030005/S248)Guidant Corp.2025-09-22
VALITUDE™ (Model U125); VALITUDE™ X4 (Model U128); VISIONIST™ (Models U225, U226); VISIONIST™ X4 (Model U228) (P030005/S246)Guidant Corp.2025-07-11
Valitude CRT-P; Valitude X4 CRT-P; Visionist CRT-P; Visionisnt X4 CRT-P (P030005/S245)Guidant Corp.2025-04-11
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S244)Guidant Corp.2024-12-18
U125 VALITUDE CRT-P, U128 VALITUDE X4 CRT-P, U225 VISIONIST CRT-P, U226 VISIONIST CRT-P, U228 VISIONIST X4 CRT-P (P030005/S243)Guidant Corp.2024-11-25
ACCOLADE (P030005/S241)Guidant Corp.2024-11-01
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S242)Guidant Corp.2024-10-23
Cardiac Resynchronization Therapy Pacemaker (CRT-P) (P030005/S240)Guidant Corp.2024-08-28
Latitude™ NXT Patient Management System (INVIVE, INTUA, VISIONIST, VALITUDE) (P030005/S238)Guidant Corp.2024-07-18
VALITUDE™, VALITUDE X4, VISIONIST™, VISIONIST X4 (P030005/S237)Guidant Corp.2024-06-04
U125 VALITUDE™ CRT-P, U128 VALITUDE™ X4 CRT-P, U225 VISIONIST™ CRT-P, U226 VISIONIST™ CRT-P, U228 VISIONIST™ X4 CRT-P (P030005/S239)Guidant Corp.2024-05-29
INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S236)Guidant Corp.2024-04-30
Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, Visionist X4 CRT-P (P030005/S235)Guidant Corp.2023-12-29
VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P (P030005/S234)Guidant Corp.2023-10-18
PG VALITUDE CRT-P IS1 EL US, PG VALITUDE CRT-P IS4 EL US, PG VISIONIST CRT-P IS1 EL US, PG VISIONIST CRT-P LV1 EL US, PG (P030005/S233)Guidant Corp.2023-10-06
VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P (P030005/S232)Guidant Corp.2023-07-21
Accolade CRT – Pacemakers (CRT-Ps) (P030005/S229)Guidant Corp.2023-05-11
VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P (P030005/S231)Guidant Corp.2023-05-08
Level VIII Controlled Environment Area (CEA), Level IX CEA Dry Room (P030005/S230)Guidant Corp.2023-05-01
INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S228)Guidant Corp.2023-04-21
PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S227)Guidant Corp.2022-12-20
CRT-P Resynchronization Devices (P030005/S222)Guidant Corp.2022-12-20
VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P (P030005/S226)Guidant Corp.2022-12-14
Accolade Family of Devices Pacemakers, and Cardiac Resynchronization Therapy Pacemakers (CRT-Ps) (P030005/S225)Guidant Corp.2022-12-12
Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S223)Guidant Corp.2022-12-12
VALITUDE™, VALITUDE™ X4, VISIONIST™, VISIONIST™ X4 (P030005/S220)Guidant Corp.2022-11-08
PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S224)Guidant Corp.2022-10-28
VALITUDE™ CRT-P, VALITUDE X4 CRT-P (P030005/S221)Guidant Corp.2022-09-27
PG Valitude CRT-P IS1 EL, PG Valitude CRT-P IS4 EL, PG Visionist CRT-P IS1 EL, PG Visionist CRT-P LV1 EL, PG Visionist C (P030005/S219)Guidant Corp.2022-07-27
PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S218)Guidant Corp.2022-07-13
CRT-P Resynchronization Devices (P030005/S215)Guidant Corp.2022-02-24
U125 VALITUDE™ CRT-P, U128 VALITUDE™ X4 CRT-P, U225 VISIONIST™ CRT-P, U226 VISIONIST™ CRT-P, U228 VISIONIST™ X4 CRT-P (P030005/S216)Guidant Corp.2021-12-23
VALITUDE™ CRT-P, VALITUDE™ X4 CRT-P, VISIONIST™ CRT-P, VISIONIST™ X4 CRT-P (P030005/S217)Guidant Corp.2021-12-21
INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S212)Guidant Corp.2021-11-30
VALITUDE™ CRT-P; VALITUDE X4 CRT-P (P030005/S214)Guidant Corp.2021-10-21
ACUITY STEERABLE LEAD SYSTEM (P050046/S032)Guidant Corp.2021-09-24
VALITUDE CRT-P, VISIONIST CRT-P (P030005/S213)Guidant Corp.2021-09-24
INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S211)Guidant Corp.2021-09-17
VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S210)Guidant Corp.2021-09-03
VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S209)Guidant Corp.2021-05-06
VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, VISIONIST X4 CRT-P (P030005/S208)Guidant Corp.2021-04-30
ACUITY Steerable Lead System (P050046/S031)Guidant Corp.2021-04-02
Contak Renewal TR, Valitude, Invive, and Intua (P030005/S207)Guidant Corp.2021-04-02
Contak Renewal (P030005/S205)Guidant Corp.2021-02-02
ACUITY™ Steerable Heart Failure Lead (P050046/S030)Guidant Corp.2021-01-13
VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P (P030005/S206)Guidant Corp.2020-12-11
VALITUDE, VALITUDE X4, VISIONIST and VISIONIST X4 (P030005/S204)Guidant Corp.2020-11-16
PG VALITUDE CRT-P and PG VISIONIST CRT-P (P030005/S203)Guidant Corp.2020-10-22
INVIVE, INTUA, VISIONIST, VALITUDE - CRT-P Resynchronization Devices (P030005/S200)Guidant Corp.2020-10-22
VALITUDE, VALITUDE X4, VISIONIST, and VISIONIST X4 CRT-P Devices (P030005/S201)Guidant Corp.2020-10-16
PG VALITUDE CRT-P, PG VISIONIST CRT-P (P030005/S202)Guidant Corp.2020-10-01
VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 - Cardiac Resynchronization Therapy Pacemaker (CRT-P) (P030005/S199)Guidant Corp.2020-09-03
CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE (P030005/S198)Guidant Corp.2020-08-03
(CRT-P Resynchronization Devices) INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S197)Guidant Corp.2020-06-15
CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S193)Guidant Corp.2020-04-01
VALITUDE CRT-P, VALITUDE X4 CRT-P, VISIONIST CRT-P, and VISIONIST X4 CRT-P (P030005/S196)Guidant Corp.2020-03-17
PG VALITUDE CRT-P, PG VISIONIST CRT-P, and INTUA CRT-P (P030005/S195)Guidant Corp.2020-03-05
PG VALITUDE CRT-P IS1 EL, IS4 EL, PG VISIONIST CRT-P IS1 EL, LV1 EL, IS4 EL (P030005/S194)Guidant Corp.2020-01-28
Valitude CRT-P, Valitude X4 CRT-P, Visionist CRT-P, and Visionist X4 CRT-P (P030005/S192)Guidant Corp.2019-12-04
Valitude CRT-P IS1/IS4 EL, Visionist CRT-P IS1 El and Visionist CRT-P LV1 EL (P030005/S191)Guidant Corp.2019-11-27
Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S190)Guidant Corp.2019-10-29
CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST, and VALITUDE (P030005/S188)Guidant Corp.2019-10-18
Valitude, Valitude X4, Visionist, and Visionist X4 Cardiac Resynchronization Therapy - Pacemaker (CRT-P) (P030005/S189)Guidant Corp.2019-09-24
Valitude and Visionist Non-MRI CRT-Ps and Valitude X4 and Visionist X4 MRI CRT-Ps (P030005/S186)Guidant Corp.2019-09-18
Visionist and Valitude (CRT-P) (P030005/S187)Guidant Corp.2019-07-18
CRT-P Resynchronization Devices: INVIVE, INTUA, VISIONIST and VALITUDE (P030005/S182)Guidant Corp.2019-07-08
INVIVE, INTUA, VISIONIST and VALITUDE CRT-P Resynchronization Devices (P030005/S184)Guidant Corp.2019-07-08
Accolade CRT – Pacemakers (CRT-Ps) (P030005/S185)Guidant Corp.2019-06-21
CRT-P Resynchronization Devices INVIVE, INTUA, VISIONIST, VALITUDE (P030005/S183)Guidant Corp.2019-06-10
VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P (P030005/S180)Guidant Corp.2019-05-23
INVIVE, INTUA, VISIONIST and VALITUDE (CRT-P Resynchronization Devices) (P030005/S179)Guidant Corp.2019-02-22
Accolade Cardiac Resynchronization Therapy Pacemakers (P030005/S181)Guidant Corp.2019-02-19
INVIVE, INTUA, VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S178)Guidant Corp.2018-11-16
INVIVE CRT-P, INTUA CRT-P, VALITUDE CRT-P, VISIONIST CRT-P, VALITUDE X4 CRT-P, VISIONIST X4 CRT-P, and Programmer Softwa (P030005/S176)Guidant Corp.2018-07-27
Acuity Steerable (P050046/S029)Guidant Corp.2018-07-26
Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software (P030005/S175)Guidant Corp.2018-04-25
Acuity Steerable Lead System (P050046/S028)Guidant Corp.2018-04-25
Invive, Intua, Visionist, Valitude (P030005/S172)Guidant Corp.2018-03-26
Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: INVIVE TM, INTUA TM, VALITUDE, VALITUDE X4, VISION (P030005/S174)Guidant Corp.2018-03-12
VALITUDE CRT-P; VALITUDE X4 CRT-P; VISIONIST (P030005/S173)Guidant Corp.2018-02-08
Ingenio CRT-P Devices (Invive, Intua), Ingenio 2 CRT-P Devices (Valitude, Valitude X4, Visiionist, Visionist X4) (P030005/S171)Guidant Corp.2018-02-02
Contak Renewal Models H125 and H120 with the Model 2865 Version 1.8 Application Software (P030005/S165)Guidant Corp.2018-01-07
Intua, Invive, Valitude, Visionist, CRT-Ps (P030005/S170)Guidant Corp.2017-12-19
Invive, Intua, Visionist, Valitude (P030005/S161)Guidant Corp.2017-12-13
Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P) Devices: VALITUDE, VALITUDE, and VISIONIST (P030005/S167)Guidant Corp.2017-12-11
VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4, INVIVE, INTUA Cardiac Resynchronization Therapy-Pacemaler (CRT-P) (P030005/S168)Guidant Corp.2017-12-06
VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 / Accolade C ardiac Resynchronization Therapy-Pacemaker (CRT-P) Device (P030005/S169)Guidant Corp.2017-12-06
Valitude, Valitude X4, Visionist, Visionist X4 (Accolade (CRT-Ps), Intua, Invive (Ingenio CRT-Ps) (P030005/S166)Guidant Corp.2017-12-01
Valitude, Valitude X4, Visionist, Visionist X4 - Accolade Cardiac Resynchronization Therapy (P030005/S163)Guidant Corp.2017-10-26
Accolade Cardiac Resynchronization Therapy-Pacemaker (CRT-P): VALITUDE, VALITUDE X4, VISIONIST, VISIONIST X4 (P030005/S164)Guidant Corp.2017-10-20
Valitude / Valitude X4 / Visionist / Visionist X4 / Accolade Cardiac Resynchronization Therapy Pacemaker (CRT-P) Devices (P030005/S162)Guidant Corp.2017-10-18
CRT-Ps: Invive, Valitude, and Visionist (P030005/S160)Guidant Corp.2017-09-25
VALITUDE / VALITUDE X4 / VISIONIST / VISIONIST X4 (P030005/S157)Guidant Corp.2017-09-21
Invive, Intua, Visionist, Valitude (P030005/S152)Guidant Corp.2017-09-11
Torque Wrench (P030005/S156)Guidant Corp.2017-09-11
Accolade Cardiac Resynchronization Therapy Pacemaker Devices- Valitude, Valitude X4, Visionist and Visionist X4 (P030005/S158)Guidant Corp.2017-08-30
CRT-P VALITUDE, VISIONIST (P030005/S159)Guidant Corp.2017-08-30
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