DXY · Class III · 21 CFR 870.3610

FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Leading manufacturers include Medtronic Vascular, Intermedics, Inc. and Telectronics, Inc..

461
Total
461
Cleared
80d
Avg days
1976
Since
461 devices
121–144 of 461
Cleared Sep 12, 1985
IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
K853206
Telectronics, Inc.
Cardiovascular · 43d
Cleared Aug 06, 1985
CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
K852435
Cardiac Control Systems, Inc.
Cardiovascular · 57d
Cleared Jul 25, 1985
ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
K853017
Ela Medical, Inc.
Cardiovascular · 8d
Cleared Jul 25, 1985
#335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
K853034
Intermedics, Inc.
Cardiovascular · 7d
Cleared Jul 19, 1985
SUPRIMA II MODEL 254-26
K852431
Intermedics, Inc.
Cardiovascular · 39d
Cleared Jul 17, 1985
SUPRIMA II MODEL 253-23
K852430
Intermedics, Inc.
Cardiovascular · 37d
Cleared Jul 17, 1985
SUPRIMA II MODEL 254-28
K852432
Intermedics, Inc.
Cardiovascular · 37d
Cleared Jun 21, 1985
MULTICOR S, MODELS 330A/331A
K851420
Cordis Corp.
Cardiovascular · 73d
Cleared Jun 18, 1985
CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS
K844360
Cordis Corp.
Cardiovascular · 217d
Cleared Jun 11, 1985
STANICOR GAMMA 333B/334A
K851416
Cordis Corp.
Cardiovascular · 63d
Cleared Jun 11, 1985
MULTICOR GAMMA MODELS 336/337
K851417
Cordis Corp.
Cardiovascular · 63d
Cleared Jun 11, 1985
OMNI-ATRICOR MODEL 308A
K851418
Cordis Corp.
Cardiovascular · 63d
Cleared Jun 11, 1985
MULTICOR GAMMA 402 SERIES PACER
K851419
Cordis Corp.
Cardiovascular · 63d
Cleared May 16, 1985
COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE
K851699
Cook Pacemaker Corp.
Cardiovascular · 22d
Cleared May 16, 1985
PROGRAMALITH III MODEL 249 PULSE GENERATOR
K851861
Pacesetter Systems
Cardiovascular · 20d
Cleared May 15, 1985
PROGRAMALITH III 240 PULSE GENERATOR
K850464
Pacesetter Systems
Cardiovascular · 97d
Cleared Apr 18, 1985
LEPTOS PULSE GENERATOR
K844794
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS-M PULSE GENERATOR
K844795
Biotronik Sales, Inc.
Cardiovascular · 129d
Cleared Apr 18, 1985
NEOS - PULSE GENERATOR
K844812
Biotronik Sales, Inc.
Cardiovascular · 128d
Cleared Apr 18, 1985
KALOS-04 PULSE GENERATOR
K844841
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 18, 1985
NEOS-LP PULSE GENERATOR
K844842
Biotronik Sales, Inc.
Cardiovascular · 127d
Cleared Apr 04, 1985
QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR
K850252
Telectronics, Inc.
Cardiovascular · 72d
Cleared Apr 04, 1985
IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II
K851081
Telectronics, Inc.
Cardiovascular · 17d
Cleared Apr 01, 1985
PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR
K850651
Pacesetter Systems
Cardiovascular · 41d