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 | RX5000 PROGRAMMER |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830026 |
Supplement Number | S076 |
Date Received | 10/07/1999 |
Decision Date | 10/29/1999 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a modification to the as shipped configuration for refurbished and repaired Rx5000 Pacemaker Programmers. Specifically, to offer the Triangular Chest Lead Cable Model 526-04 as a purchasable accessory and no longer include it with the shipped units. |
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