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 | MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66 |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910020 |
Supplement Number | S013 |
Date Received | 12/14/1995 |
Decision Date | 05/03/1996 |
Withdrawal Date
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07/20/2012 |
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 THE MARATHON FAMILY OF PULSE GENERATORS AND THE MODEL 531-66 GRAPHICS PROGRAM MODULE. THE MARATHON FAMILY OF PULSE GENERATORS CONSISTS OF THE FOLLOWING MODELS: - MARATHON DR MODELS 294-09, 293-09, 294-09R, 294-10; MARATHON SR MODELS 292-09, 291-09, 292-09R, 292-10, 292-09X; COSMOS 3 MODELS 283-09, 284-09, 284-09R |
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