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 | COSMO, STRIDE, DASH, DART, UNITY, NOVA, QUANTUM PULSE GENERATORS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830026 |
Supplement Number | S071 |
Date Received | 02/19/1998 |
Decision Date | 05/21/1998 |
Product Code |
LWP |
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 following pacemakers whcih incorporate the Edgeband Design: Cosmos 3 Model 284-09E; Cosmos II Model 284-05E; Stride Model 294-05E; Dash Model 292-03E; Dart Model 292-05E; Unity Model 292-07E; Nova III Model 282-07E; and theQuantum III Model 254-27E. In addition approval for the use of an alternate packaging of Polyethylene Terephthalate Glycol (PETG) for all the Edgeband models listed above and the following additional models: the Side-Lock(TM) implantable pulse generator models 282-07, 254-27, and 254-31, and the Nova II Model 281-05 and Nova III Model 282-04 pulse generators. |
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