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 | RELIANCE/RELIANCE S |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P910073 |
Supplement Number | S035 |
Date Received | 09/13/2000 |
Decision Date | 11/02/2000 |
Product Code |
LWS |
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 LUBRICIOUS COATING, REMOVAL OF ONE SUTURE SLEEVE (ON MODELS 127, 128, 147, 148), REDUCTION OF THE YOKE (ON MODELS 147, 148, 149), AND ADDITION OF THE PUERTO RICO FACILITY FOR PACKAGING, LABELING, AND STERILIZATION. |
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