| LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP (K903928) | Biotronik, GmbH & Co. | 1990-10-16 |
| LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP (K903929) | Biotronik, GmbH & Co. | 1990-10-16 |
| MODELS 5069/5071 MYOCARDIAL PACING LEADS (K902002) | Medtronic Vascular | 1990-09-26 |
| BIOTRONIK'S PS-ENDOCARDIAL LEADS (K896824) | Biotronik, GmbH & Co. | 1990-08-08 |
| LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING (K900645) | Telectronics Pacing Systems, Inc. | 1990-08-08 |
| FOCUS J81F, J83F, J41F, J43F PACING LEADS (K896742) | Ela Medical, Inc. | 1990-07-17 |
| ENDOCARDIAL SCREW-IN LEAD MODEL 1028T (K902147) | Pacesetter Systems | 1990-07-17 |
| VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458 (K901402) | Telectronics Pacing Systems, Inc. | 1990-06-12 |
| DNP 60-B UNIPOLAR ENDOCARDIAL LEAD (K901709) | Biotronik, GmbH & Co. | 1990-05-22 |
| MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1 (K900984) | Medtronic Vascular | 1990-05-03 |
| FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T (K900550) | Pacesetter Systems | 1990-04-20 |
| MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN. (K896313) | Medtronic Vascular | 1990-03-06 |
| PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA (K895136) | Medtronic Vascular | 1990-02-08 |
| MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES (K897067) | Telectronics Pacing Systems, Inc. | 1990-02-05 |
| FIVE-YEAR STERILE PACKAGING SHELF LIFE (K892528) | Daig Corp. | 1990-01-18 |
| MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS (K896443) | Possis Medical, Inc. | 1989-12-20 |
| ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (K895447) | Pacesetter Systems | 1989-12-20 |
| NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI (K893041) | Telectronics Pacing Systems, Inc. | 1989-11-14 |
| MODELS 1113 AND 1114 PACEMAKER LEADS (K893763) | Possis Medical, Inc. | 1989-07-14 |
| IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR (K894040) | Medtronic Vascular | 1989-07-14 |
| MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS (K885175) | Possis Medical, Inc. | 1989-07-14 |
| PACEMAKER LEAD ADAPTER (K890018) | Ela Medical, Inc. | 1989-06-20 |
| CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (K891905) | Pacesetter Systems | 1989-06-05 |
| MEDTRONIC MODEL 5866-45 SIZING SLEEVE (K890644) | Medtronic Vascular | 1989-05-31 |
| ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS (K890527) | Medtronic Vascular | 1989-04-21 |
| HEPARIN BONDING FOR CATHETERS (K884697) | Daig Corp. | 1989-04-19 |
| MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS (K890411) | Intermedics, Inc. | 1989-03-28 |
| MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS (K890412) | Intermedics, Inc. | 1989-03-28 |
| SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS (K890547) | Pacesetter Systems | 1989-03-22 |
| ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS (K884811) | Telectronics and Control Pacing Systems | 1989-02-22 |
| MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD (K885240) | Tpl-Cordis, Inc. | 1989-02-10 |
| VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) (K890350) | Telectronics, Inc. | 1989-02-02 |
| MODEL 6208,6209,6210,6211,6212,6214 (PLI'S) (K890045) | Medtronic Vascular | 1989-01-30 |
| MEDTRONIC MODEL 4058 PACING LEAD (K883743) | Medtronic Vascular | 1989-01-17 |
| IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 (K884278) | Telectronics, Inc. | 1988-12-15 |
| PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F (K884394) | Ela Medical, Inc. | 1988-12-08 |
| ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED (K884005) | Medtronic Vascular | 1988-12-05 |
| ENCOR UNIPOLAR VS-1 LEADS (K883070) | Cordis Leads, Inc. | 1988-12-05 |
| PERMANENT PACING LEADS PYBJ SERIES (K882345) | Oscor Medical Corp. | 1988-10-28 |
| PERMANENT PACING LEAD MODEL RXBJ SERIES (K882462) | Oscor Medical Corp. | 1988-10-28 |
| CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS (K873772) | Cordis Leads, Inc. | 1988-10-19 |
| MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD (K883265) | Telectronics and Cordis Pacing Systems | 1988-10-14 |
| POLYSAFE(TM) IMPLANTABLE PACING LEAD (K884024) | Cardiac Control Systems, Inc. | 1988-10-14 |
| MEDTRONIC MODEL 4951P (K881810) | Medtronic Vascular | 1988-10-13 |
| POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP (K883015) | Cardiac Control Systems, Inc. | 1988-10-06 |
| POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP (K883016) | Cardiac Control Systems, Inc. | 1988-09-16 |
| MODEL 5866-34A PACEMAKER LEAD ADAPTOR (K883203) | Medtronic Vascular | 1988-09-06 |
| BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD (K883602) | Intermedics, Inc. | 1988-09-06 |
| MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD (K882452) | Medtronic Vascular | 1988-08-25 |
| ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201 (K874366) | Cordis Leads, Inc. | 1988-06-16 |
| IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 (K874664) | Telectronics, Inc. | 1988-05-31 |
| MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT (K881712) | Medtronic Vascular | 1988-05-25 |
| MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD (K875178) | Intermedics, Inc. | 1988-05-25 |
| MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD (K875100) | Intermedics, Inc. | 1988-05-24 |
| MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD (K872126) | Intermedics, Inc. | 1988-03-22 |
| MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD (K880551) | Intermedics, Inc. | 1988-03-07 |
| NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR (K875199) | Biotronik Sales, Inc. | 1988-02-18 |
| PERMANENT MYOCARDIAL LEADS MP SERIES (K872971) | Oscor Medical Corp. | 1988-02-12 |
| MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD (K873962) | Medtronic Vascular | 1988-02-02 |
| ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T (K874205) | Pacesetter Systems | 1988-02-02 |
| ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD (K874183) | Daig Corp. | 1988-01-29 |
| PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390 (K874743) | Pace Medical | 1988-01-19 |
| MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD (K874792) | Medtronic Vascular | 1988-01-19 |
| POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD (K874531) | Intermedics, Inc. | 1988-01-07 |
| MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER (K874930) | Intermedics, Inc. | 1988-01-06 |
| MEDTRONIC PERMANENT LEAD INTRODUCER (K874167) | Medtronic Vascular | 1987-12-07 |
| MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE (K873921) | Intermedics, Inc. | 1987-12-03 |
| MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD (K870885) | Medtronic Vascular | 1987-11-06 |
| MODIFIED MODELS 1025M & 1026T PACING LEAD (K873931) | Pacesetter Systems | 1987-10-22 |
| PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860 (K872731) | Ela Medical, Inc. | 1987-09-15 |
| SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 (K865098) | Telectronics, Inc. | 1987-08-18 |
| ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG) (K870016) | Migada, Ltd. | 1987-05-28 |
| IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 (K871580) | Intermedics, Inc. | 1987-05-22 |
| IMPLANTABLE ELECTRODE LEAD, MODEL 030-439 (K864618) | Telectronics, Inc. | 1987-05-21 |
| MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER (K871625) | Intermedics, Inc. | 1987-05-21 |
| ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY (K870357) | Intermedics, Inc. | 1987-05-21 |
| IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL (K871333) | Medtronic Vascular | 1987-05-06 |
| MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD (K870948) | Intermedics, Inc. | 1987-04-10 |
| RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE (K870610) | Telectronics, Inc. | 1987-03-20 |
| ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035 (K870824) | Pacesetter Systems | 1987-03-20 |
| MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD (K870034) | Oscor Medical Corp. | 1987-03-03 |
| MODEL 366-13 ADAPTAID STEP DOWN ADAPTER (K864326) | Intermedics, Inc. | 1987-01-16 |
| MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD (K862051) | Intermedics, Inc. | 1987-01-06 |
| MODEL 5866-24 PACEMAKER LEAD ADAPTOR (K864856) | Medtronic Vascular | 1987-01-06 |
| MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP (K864738) | Intermedics, Inc. | 1987-01-06 |
| PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 (K864153) | Pace Medical | 1987-01-06 |
| ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD (K864640) | Cordis Corp. | 1987-01-06 |
| MEDTRONIC MODEL 5013 (K863536) | Medtronic Vascular | 1987-01-06 |
| CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD (K864601) | Cardiac Control Systems, Inc. | 1987-01-06 |
| MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER (K864428) | Intermedics, Inc. | 1986-12-05 |
| MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD (K864564) | Intermedics, Inc. | 1986-12-05 |
| TELECTRONICS SREW-IN/SLIM LINE PACING LEADS (K864098) | Daig Corp. | 1986-12-05 |
| DAIG TYPE O4 VS-1 CONNECTOR (K863921) | Daig Corp. | 1986-11-24 |
| MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD (K864287) | Intermedics, Inc. | 1986-11-20 |
| MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD (K864002) | Intermedics, Inc. | 1986-11-20 |
| MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD (K863781) | Intermedics, Inc. | 1986-11-03 |
| MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER (K864048) | Intermedics, Inc. | 1986-11-03 |
| MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER (K864047) | Intermedics, Inc. | 1986-11-03 |
| 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1) (K862966) | Oscor Medical Corp. | 1986-10-31 |
| BIOTRONIK PERMANENT PACEMAKER ELECTRODE (K863480) | Biotronik Sales, Inc. | 1986-09-23 |