Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR |
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 | S006 |
Date Received | 04/25/1989 |
Decision Date | 07/31/1989 |
Withdrawal Date
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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 |
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