Atlas FDA

PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM

FDA 510(k) clearance K122459 · decided 2012-12-13

Clearance details

K-number
K122459
Device name
PINNACLE LITE PELVIC FLOOR REPAIR KIT, POSTERIOR UPHOLD LITE VAGINAL SUPPORT SYSTEM
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2012-08-13
Decision date
2012-12-13
Days to decision
122 days
Clearance type
Abbreviated
Product code
OTP
Device class
3
Regulation number
884.5980
Medical specialty
Obstetrics/Gynecology
Advisory committee
Obstetrics/Gynecology
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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AMS ELEVATE PC APICAL AND POSTERIOR ( AND ANTERIOR AND APICAL) PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE (K111118)American Medical Systems2011-07-01
RESTORELLE POLYPROPYLENE MESH (K092207)Mpathy Medical Devices, Inc.2009-08-04
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EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEMS (K083499)Coloplast A/S2009-05-08
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Recalls involving this device

RecordFirmDate
Uphold LITE w/ Capio SLIM; Model #M0068318170. Indicated for tissue reinforcement in women recall (Z-1622-2018)Boston Scientific Corporation2018-05-04
Posterior LITE w/ Capio SLIM; Model #M0068318150. Indicated for tissue reinforcement in wo recall (Z-1623-2018)Boston Scientific Corporation2018-05-04

PMA approvals by this applicant

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Ranger™ Paclitaxel-Coated Balloon Catheter (P190019/S043)Boston Scientific Corporation2026-08-04
AGENT™ Paclitaxel-Coated Balloon Catheter (P230035/S009)Boston Scientific Corporation2026-07-30
Axonics Sacral Neuromodulation System (P180046/S110)Boston Scientific Corporation2026-07-24
Axonics Sacral Neuromodulation System (P190006/S110)Boston Scientific Corporation2026-07-24
S-ICD EMBLEM™ GEN 2 (A209); S-ICD EMBLEM™ MRI (A219) (P110042/S215)Boston Scientific Corporation2026-07-23