FDA Product Code DXY: Implantable Pacemaker Pulse-generator

Cleared Sep 24, 1986

MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE

K863418

Intermedics, Inc.

Cardiovascular · 21d

Cleared Sep 04, 1986

ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.

K862974

Medtronic Vascular

Cardiovascular · 29d

Cleared Jul 01, 1986

MODIFIED MODELS 8320/8322/8329/8316/8317/8318

K861719

Medtronic Vascular

Cardiovascular · 60d

Cleared Jun 17, 1986

MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN

K862037

Medtronic Vascular

Cardiovascular · 20d

Cleared Jun 17, 1986

MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER

K862038

Medtronic Vascular

Cardiovascular · 20d

Cleared Jun 17, 1986

MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN

K862071

Medtronic Vascular

Cardiovascular · 18d

Cleared Mar 17, 1986

MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS

K855147

Medtronic Vascular

Cardiovascular · 83d

Cleared Feb 28, 1986

ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS

K854482

Medtronic Vascular

Cardiovascular · 113d

Cleared Jan 14, 1986

CORDIS MULTICOR ST, MODEL 350A

K851968

Cordis Corp.

Cardiovascular · 252d

Cleared Dec 03, 1985

MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE

K854214

Cordis Corp.

Cardiovascular · 47d

Cleared Nov 08, 1985

SUPRIMA MODEL 254-22

K852339

Intermedics, Inc.

Cardiovascular · 158d

Cleared Nov 08, 1985

SUPRIMA MODEL 254-24

K852340

Intermedics, Inc.

Cardiovascular · 158d

Cleared Nov 01, 1985

MEDTRONICS MODELS 8320/8322/8329

K852688

Medtronic Vascular

Cardiovascular · 129d

Cleared Nov 01, 1985

CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK

K852748

Cordis Corp.

Cardiovascular · 127d

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