Atlas FDA

DTB

487 FDA 510(k) clearances · Product code

79 daysmedian time to decision
231 days90th percentile
487clearances measured

FDA profile

Official device name
Permanent Pacemaker Electrode
Device class
Class III (high risk)
Regulation
21 CFR 870.3680
Medical specialty
Cardiovascular
Flags
Implant
Adverse events (MAUDE)
2021: 18,441 · 2022: 19,444 · 2023: 34,542 · 2024: 25,689 · 2025: 25,912 · 2026: 15,521
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
BIOTRONIK ENDOCARDIAL PACING LEADS (K061212)Biotronik, Inc.2006-07-10
PERMANENT PACING LEAD, MODEL PY2 (K041809)Oscor, Inc.2004-08-06
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (K040569)Oscor, Inc.2004-04-07
MODEL 5071 MYOCARDIAL PACING LEAD (K031274)Medtronic Vascular2003-05-22
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (K031210)Metronic, Inc.2003-05-16
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205)Biotronik, Inc.2003-04-24
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (K024053)Oscor, Inc.2003-01-31
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (K023803)Biotronik, Inc.2002-12-11
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (K023099)Biotronik, Inc.2002-10-18
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217)Biotronik, Inc.2002-05-01
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (K010281)Biotronik, Inc.2002-04-09
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB (K020669)Oscor, Inc.2002-03-28
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS (K013339)Oscor, Inc.2001-11-08
OSCOR PERMANENT PACING LEAD RZ MODEL SERIES (K003918)Oscor, Inc.2001-05-22
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES (K003072)Biotronik, Inc.2001-01-09
ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668 (K001413)Biotronik, Inc.2000-06-02
EX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133 (K994240)Biotronik, Inc.2000-04-13
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS (K993448)Ela Medical, Inc.2000-04-10
PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 (K000763)Biotronik, GmbH & Co.2000-04-06
STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAPED TINED PACING LEADS (K000029)Ela Medical, Inc.2000-04-04
YP 45/15-BP; YP 53/15-BP; YP 60/15-BP (K993139)Biotronik, Inc.1999-12-17
HT, MODEL HT PB (K990142)Sulzer Oscor, Inc.1999-07-30
SX 53/15-BP, MODEL 124 853, SX 60/15-BP, MODEL 124 854 (K991169)Biotronik, Inc.1999-07-01
RETROX RX 45-JBP 124774, 53-JBP 124775, 53-BP 124776, 60-124777 (K990483)Biotronik, Inc.1999-06-03
SYNOX SX 53-BP, SX 60-BP, SX 45-JBP, SX 53-JBP , MODELS 120 444, 119 684, 120 438 AND 120 143 (K980869)Biotronik, Inc.1998-09-10
RETROX RX 53-BP, RETROX RX 60-BP, RETROX RX 45-JBP, RETROX RX 53-JBP MODEL NUMBERS 124 396, 124 397, 124 395, 124 000 (K981083)Biotronik, Inc.1998-07-22
TIR/TIJ AND POLYROX (K972500)Biotronik, Inc.1998-03-04
LOCATOR MODEL 4036 (K972814)Pacesetter, Inc.1998-02-23
ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606 (K965106)Biotronik, Inc.1998-01-27
STELA MODEL UJ45 PACING LEADS (K972574)Ela Medical, Inc.1998-01-08
STELA MODEL BJ44 AND BJ45 PACING LEADS (K963738)Ela Medical, Inc.1997-05-23
OSCOR PERMANENT RETRACTABLE SCREW-IN PACING LEAD MODEL PR (K964107)Oscor Medical Corp.1997-04-01
BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION AND PASSIVE FIXATION (K964604)Biotronik, Inc.1997-03-10
MODEL 430-07 ENDOCARDIAL PACING LEAD (K954610)Intermedics, Inc.1996-12-16
INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD (K955122)Intermedics, Inc.1996-11-04
UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION & PASSIVE FIXATION (K953044)Biotronik, Inc.1996-09-27
MEDTRONIC MODEL 5058 BIPOLAR, IMPLANTABLE, SCREW-IN, VENTRICULAR/ATRIAL, TRANSVENOUS LEAD (K962036)Medtronic Vascular1996-08-22
BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) (K962174)Intermedics, Inc.1996-08-21
MODEL 2188 CORONARY SINUS LEAD. (K961936)Medtronic Vascular1996-08-15
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS (K961679)Medtronic Vascular1996-07-30
MAXIM PF MODELS 033-581/033-590 (K961118)Telectronics Pacing Systems, Inc.1996-07-15
STERILIZATION (K943657)Telectronics Pacing Systems, Inc.1996-06-24
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD (K955550)Intermedics, Inc.1996-06-19
IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY (K960281)Intermedics, Inc.1996-06-18
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD (K954719)Intermedics, Inc.1996-02-27
AFP CARDIAC PACING SYSTEM MODEL 283 (MODIFICATION) (K954714)Pacesetter, Inc.1996-02-01
DF-1 TERMINAL CAP (K954551)Pacesetter, Inc.1995-12-26
MODELS 5866-45 AND 5866-46 SIZING SLEEVE (K954085)Medtronic Vascular1995-11-07
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS (K951858)Medtronic Vascular1995-10-12
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (K951950)Pacesetter, Inc.1995-08-31
PASSIVE PLUS PACING LEADS WITH TITANIUM NITRIDE COATING (K952206)Pacesetter, Inc.1995-08-31
TENDRIL, UNIPOLAR ENDOCARDIAL SCREW-IN LEAD (K951087)Pacesetter, Inc.1995-06-29
MEDTRONIC MODEL 4558M (K940703)Medtronic Vascular1994-11-04
AFP CARDIAC PACING SYSTEM MODEL 283 (K942440)Siemens-Pacesetter, Inc.1994-08-08
PACING LEAD MODEL 1188T (K925038)Siemens-Pacesetter, Inc.1994-07-15
PASSIVE PLUS ENDOCARDIAL PACING LEADS VAR. MODELS (K932892)Siemens-Pacesetter, Inc.1994-07-06
SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T (K930876)Siemens-Pacesetter, Inc.1994-06-15
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF (K933055)Medtronic Vascular1994-05-02
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD (K933731)Medtronic Vascular1994-03-21
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS (K932172)Medtronic Vascular1993-12-08
VASCOTWIST 9/60 (K920662)Vascor Medical Corp.1993-11-24
MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L (K931411)Medtronic Vascular1993-09-23
VASCO TIP/VASCOFLANGE (K913831)Vascor Medical Corp.1993-08-25
VASCOSCREW 6/60 AND VASCOSCREW 8/60 (K914121)Vascor Medical Corp.1993-08-24
MAXIMA FILTERED HARDSHELL RESERVOIR (K932254)Medtronic Vascular1993-08-03
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA (K925099)Possis Medical, Inc.1993-06-22
MODEL 1148T TRANSVENOUS, SCREW-IN LEAD (K925347)Siemens-Pacesetter, Inc.1993-06-10
CARDIFIX ENDOCARDIAL PACING LEAD (K922042)Intermedics, Inc.1993-04-29
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (K920822)Siemens-Pacesetter, Inc.1993-01-22
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD (K922972)Intermedics, Inc.1993-01-22
MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING (K915736)Medtronic Vascular1992-12-03
MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD (K915188)Cook Pacemaker Corp.1992-09-11
NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING (K914489)Telectronics Pacing Systems, Inc.1992-08-17
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS (K921124)Medtronic Vascular1992-05-22
PERMANENT CARDIAC PACING LEADS AND ADAPTORS (K912464)Medtronic Vascular1992-02-11
OSCOR MEDICAL CORP PERMANENT PACING LEAD (K912867)Oscor Medical Corp.1992-02-04
PERMANENT PACING PAD, MODIFICATION (K915008)Oscor Medical Corp.1992-01-27
PERMANENT PACING LEADS, MODIFICATION (K915007)Oscor Medical Corp.1992-01-27
MEDTRONIC UNIPOLAR, POLY PAC LEAD-BARR COAT COILS (K913288)Medtronic Vascular1991-10-17
PRODUCTS IMPLANT PACING LEAD, TINED, MODIFICATION (K913201)Oscor Medical Corp.1991-09-23
IMPLANT PACING LEAD TINED #3390, MODIFICATION (K913203)Oscor Medical Corp.1991-09-23
OSCOR MEDICAL FIX SCREW PAC LEAD/PEEL CATH, MODIF (K913205)Oscor Medical Corp.1991-09-23
MODEL KY PACEMAKER LEAD-VARIOUS, MODIFICATION (K913204)Oscor Medical Corp.1991-09-23
IMPLANT PACING LEAD, TINED #3262, MODIFICATION (K913202)Oscor Medical Corp.1991-09-23
IMPLANT PACING LEAD, RETRACTABLE, MODIFICATION (K913393)Oscor Medical Corp.1991-09-23
MODIFIED OSCOR PY PACING LEADS/MODIFICATION (K913158)Oscor Medical Corp.1991-09-23
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD (K912235)Intermedics, Inc.1991-09-18
100 CM PERMANENT PACING LEAD MODELS (K911273)Telectronics Pacing Systems, Inc.1991-08-28
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE (K910924)Pacesetter Systems1991-08-28
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (K910609)Biotronik, GmbH & Co.1991-08-28
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS (K910528)Possis Medical, Inc.1991-08-09
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP (K910608)Biotronik, GmbH & Co.1991-07-30
PERMANENT PACING LEAD (K905300)Oscor Medical Corp.1991-05-07
OSCOR MEDICAL CORP. PERMANENT PACING PAD (K905182)Oscor Medical Corp.1991-05-07
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD (K903948)Intermedics, Inc.1991-04-22
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD (K902672)Intermedics, Inc.1991-03-01
FOCUS T41,T41F,T43, T43F,T44F (K904255)Elamedical1991-01-18
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES (K904741)Telectronics Pacing Systems, Inc.1991-01-08
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN (K903221)Telectronics Pacing Systems, Inc.1990-11-08
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP (K903927)Biotronik, GmbH & Co.1990-10-16
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