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 | MOMENTUM PACERS |
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 | S020 |
Date Received | 01/08/1998 |
Decision Date | 01/30/1998 |
Withdrawal Date
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07/20/2012 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Edgeband Design on the Marathon SR Model 292-09, Relay Model 293-03, Marathon DR Model 293-09, Marathon DR Model 294-09, and Mementum DR Model 294-23. The devices, as modified, will be marketed under the trade name Edgeband pacemakers, with the following models: Marathon SR Model 292-09E, Relay Model 293-03E, Marathone DR Model 293-09E, Marathon DR Model 294-09E, and Momentum DR Model 294-23E. The supplement also requested approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all Edgeband and all Side-Lock(TM) pulse generator models. |
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