|
Device | KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS. |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | COOK PACEMAKER CORP. ROUTE 66 RIVER RD. P.O. BOX 529 LEECHBURG, PA 15656 |
PMA Number | P870054 |
Supplement Number | S014 |
Date Received | 06/08/1995 |
Decision Date | 07/12/1995 |
Withdrawal Date
|
12/01/2004 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE IN THE ACCELERATED BURN-IN PROCEDURE ON THE LITHIUM/IODINE POWER SOURCE (BATTERY) BY THE VENDOR |