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
241–264 of 487
Cleared Jan 08, 1983
ELECTRODE LEAD OF SILICONE ELASTOMETER
K823452
Telectronics, Inc.
Cardiovascular · 52d
Cleared Dec 30, 1982
ELECTRODE, PACEMAKER, PERMANENT
K823033
Pacesetter Systems
Cardiovascular · 77d
Cleared Dec 03, 1982
PRODUCTS IMPLANTABLE PACING LEAD,TINED
K823446
Oscor, Inc.
Cardiovascular · 17d
Cleared Dec 03, 1982
IMPLANTABLE PACING LEAD TINED #3390 &
K823448
Oscor, Inc.
Cardiovascular · 17d
Cleared Nov 30, 1982
MEDTRONIC MODELS 4011 & 4511
K822781
Medtronic Vascular
Cardiovascular · 77d
Cleared Aug 06, 1982
MEDTRONIC #6993
K820989
Medtronic Vascular
Cardiovascular · 121d
Cleared Aug 06, 1982
POROUS SURFACED PLATINUM IRIDIUM
K821889
Cordis Corp.
Cardiovascular · 42d
Cleared Aug 06, 1982
FASTPASS IMPLANTABLE ENDOCARD. PACING
K821947
Pacesetter Systems
Cardiovascular · 37d
Cleared Apr 16, 1982
IMPLANTIBLE SUTURE SLEEVE
K820487
Intermedics, Inc.
Cardiovascular · 52d
Cleared Apr 09, 1982
BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60
K820767
Siemens Elema AB
Cardiovascular · 18d
Cleared Feb 12, 1982
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD.
K820121
Telectronics, Inc.
Cardiovascular · 25d
Cleared Jan 28, 1982
INTERSEPT CARDIOTOMY RESERVOIR/FILTER
K813205
Extracorporeal Medical Specialities, Inc.
Cardiovascular · 76d
Cleared Dec 10, 1981
POLY-FLEX PACING LEADS
K813028
Intermedics, Inc.
Cardiovascular · 43d
Cleared Dec 10, 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP
K813134
Telectronics, Inc.
Cardiovascular · 35d
Cleared Nov 27, 1981
ELECTRODE, PACEMAKER, PERMANENT
K810139
Pacesetter Systems
Cardiovascular · 310d
Cleared Nov 27, 1981
PACEPATH IMPLANT. ENDOCARD. PACING LEAD
K810286
Pacesetter Systems
Cardiovascular · 298d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD
K812989
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD
K812990
Intermedics, Inc.
Cardiovascular · 21d
Cleared Nov 16, 1981
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD
K812991
Intermedics, Inc.
Cardiovascular · 21d
Cleared Oct 29, 1981
MODEL 833 ENDOCARDIAL TINED LEAD
K812815
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 29, 1981
MODEL 841 ENDOCARDIAL TINED LEAD
K812816
Pacesetter Systems
Cardiovascular · 22d
Cleared Oct 23, 1981
MEDTRONIC #4951
K812599
Medtronic Vascular
Cardiovascular · 39d
Cleared Oct 13, 1981
ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J
K811593
Telectronics, Inc.
Cardiovascular · 127d
Cleared Oct 06, 1981
INTERMEDICS POLY FLEX EPICARDIAL SUTURE
K812221
Intermedics, Inc.
Cardiovascular · 60d