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 | MEDTRONIC SINGLE CHAMBER PACEMAKERS |
Generic Name | Pulse-generator, single chamber, sensor driven, implantable |
Applicant | MEDTRONIC Inc. 8200 Coral Sea Street NE Mounds View, MN 55112 |
PMA Number | P850051 |
Supplement Number | S051 |
Date Received | 07/10/1995 |
Decision Date | 10/31/1995 |
Product Code |
LWO |
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 THE ADDITION OF THREE MODELS OF PULSE GENERATORS TO YOUR ACTIVITRAX CARDIAC PACING SYSTEM. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAEM OF PREVAIL (MODELS 8084, 8085, AND 8086) USING MODEL 9885E SOFTWARE WITH THE ALREADY APPROVED PROGRAMMERS MODELS 9760 AND 9790, AND MOMORYMOD MODEL 9773 FOR USE WITH THE ALREADY APPROVED MODEL 9710A PROGRAMMER. |
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