DTB · Class III · 21 CFR 870.3680

FDA Product Code DTB: Permanent Pacemaker Electrode

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

487
Total
479
Cleared
119d
Avg days
1976
Since
487 devices
73–96 of 487
Cleared Sep 18, 1991
MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD
K912235
Intermedics, Inc.
Cardiovascular · 127d
Cleared Aug 28, 1991
PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP
K910609
Biotronik, GmbH & Co.
Cardiovascular · 197d
Cleared Aug 28, 1991
ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE
K910924
Pacesetter Systems
Cardiovascular · 176d
Cleared Aug 28, 1991
100 CM PERMANENT PACING LEAD MODELS
K911273
Telectronics Pacing Systems, Inc.
Cardiovascular · 159d
Cleared Aug 09, 1991
BIPOLAR SUTURELESS MYOCARDIAL PACING LEADS
K910528
Possis Medical, Inc.
Cardiovascular · 182d
Cleared Jul 30, 1991
PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP
K910608
Biotronik, GmbH & Co.
Cardiovascular · 168d
Cleared May 07, 1991
OSCOR MEDICAL CORP. PERMANENT PACING PAD
K905182
Oscor Medical Corp.
Cardiovascular · 169d
Cleared May 07, 1991
PERMANENT PACING LEAD
K905300
Oscor Medical Corp.
Cardiovascular · 161d
Cleared Apr 22, 1991
INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD
K903948
Intermedics, Inc.
Cardiovascular · 238d
Cleared Mar 01, 1991
INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD
K902672
Intermedics, Inc.
Cardiovascular · 256d
Cleared Jan 08, 1991
LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES
K904741
Telectronics Pacing Systems, Inc.
Cardiovascular · 82d
Cleared Nov 08, 1990
LASERDISH SILICONE VENTRICULAR LEAD W/TRAILING TIN
K903221
Telectronics Pacing Systems, Inc.
Cardiovascular · 108d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP
K903927
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
K903928
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Oct 16, 1990
LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
K903929
Biotronik, GmbH & Co.
Cardiovascular · 57d
Cleared Sep 26, 1990
MODELS 5069/5071 MYOCARDIAL PACING LEADS
K902002
Medtronic Vascular
Cardiovascular · 147d
Cleared Aug 08, 1990
BIOTRONIK'S PS-ENDOCARDIAL LEADS
K896824
Biotronik, GmbH & Co.
Cardiovascular · 247d
Cleared Aug 08, 1990
LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
K900645
Telectronics Pacing Systems, Inc.
Cardiovascular · 180d
Cleared Jul 17, 1990
FOCUS J81F, J83F, J41F, J43F PACING LEADS
K896742
Ela Medical, Inc.
Cardiovascular · 229d
Cleared Jul 17, 1990
ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
K902147
Pacesetter Systems
Cardiovascular · 63d
Cleared Jun 12, 1990
VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
K901402
Telectronics Pacing Systems, Inc.
Cardiovascular · 78d
Cleared May 22, 1990
DNP 60-B UNIPOLAR ENDOCARDIAL LEAD
K901709
Biotronik, GmbH & Co.
Cardiovascular · 39d
Cleared May 03, 1990
MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
K900984
Medtronic Vascular
Cardiovascular · 63d
Cleared Apr 20, 1990
FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
K900550
Pacesetter Systems
Cardiovascular · 73d