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 | LEGEND II MODELS 8424,8426,8427 AND 8430 PULSE G. |
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 | S032 |
Date Received | 05/30/1991 |
Decision Date | 11/25/1991 |
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 |
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