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
265–288 of 487
Cleared Dec 27, 1984
MEDTRONIC 6957
K843706
Medtronic Vascular
Cardiovascular · 97d
Cleared Sep 24, 1984
ELECTRODE PACEMAKER, PERM & TEMP
K840668
Vitatron Medical BV
Cardiovascular · 237d
Cleared Sep 24, 1984
LIFELINE TLE 476-04
K843393
Intermedics, Inc.
Cardiovascular · 26d
Cleared Sep 24, 1984
LIFELINE TLE 484-02
K843394
Intermedics, Inc.
Cardiovascular · 26d
Cleared Mar 12, 1984
PACING ELECTRODE
K834431
Pacesetter Systems
Cardiovascular · 87d
Cleared Feb 04, 1984
CCS MODEL AV-102 IMPLANTABLE A-V DATA
K834342
Cardiac Control Systems, Inc.
Cardiovascular · 54d
Cleared Jan 30, 1984
ELECTRODE LEAD CONSTRUCTION
K834533
Telectronics, Inc.
Cardiovascular · 39d
Cleared Dec 01, 1983
ENDOCARDIAL SCREW-IN LEAD 859 & 861
K833824
Pacesetter Systems
Cardiovascular · 31d
Cleared Oct 20, 1983
IMPLANTABLE ENDOCARDIAL PACING LEADS
K831997
Oscor, Inc.
Cardiovascular · 121d
Cleared Oct 20, 1983
PERMANTHANE #866 BIPOLAR COAXIAL
K832987
Pacesetter Systems
Cardiovascular · 49d
Cleared Oct 20, 1983
BIOTRONIK N, BIPOLAR PEB-60/4-N
K833099
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 20, 1983
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH
K833106
Biotronik Sales, Inc.
Cardiovascular · 38d
Cleared Oct 19, 1983
BIOTRONIK DN UNIPOLAR PE-60/4-DN &
K833098
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC
K833101
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK D2K UNIPOLAR PE-60/4
K833104
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Oct 19, 1983
BIOTRONIK I-UNIPOLAR PE-60/2-13
K833108
Biotronik Sales, Inc.
Cardiovascular · 37d
Cleared Aug 12, 1983
ELECTRODE LEADS 030-267 & 030-268
K832110
Telectronics, Inc.
Cardiovascular · 43d
Cleared Aug 12, 1983
UNIPOLAR-E ENDOCARDIAL TINED LEAD
K832245
Cook Pacemaker Corp.
Cardiovascular · 32d
Cleared Aug 12, 1983
MODEL F UNIPOLAR ENDOCARDIAL LEAD-
K832255
Cook Pacemaker Corp.
Cardiovascular · 32d
Cleared Aug 12, 1983
LIFELINE PACING LEADS #471-07 &09
K832409
Intermedics, Inc.
Cardiovascular · 22d
Cleared Jul 26, 1983
IMPLANTABLE CARDIAC PACING LEADS
K831767
Oscor, Inc.
Cardiovascular · 55d
Cleared Jul 26, 1983
MEDTRONIC MODELS 4012 & 4512
K832099
Medtronic Vascular
Cardiovascular · 27d
Cleared Jun 30, 1983
CCS MODEL SJ-103 IMPLANTABLE ATRIAL
K831529
Cardiac Control Systems, Inc.
Cardiovascular · 49d
Cleared Jun 08, 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435
Pacesetter Systems
Cardiovascular · 35d