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 | CCS MODEL 333 PACEMAKER SYSTEM |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | CARDIAC CONTROL SYSTEMS, INC. 3 COMMERCE BLVD. PALM COAST, FL 32164 |
PMA Number | P890039 |
Supplement Number | S008 |
Date Received | 06/04/1992 |
Decision Date | 06/24/1993 |
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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