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 | VIGOR MODEL 2880 SOFTWARE APPLICATION |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P840068 |
Supplement Number | S029 |
Date Received | 03/25/1996 |
Decision Date | 11/07/1996 |
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 1)NEW PROGRAMMING SYSTEM, WITH MODEL 2901 PRM PROGRAMMING SYSTEM WITH THE COMMERCIALLY AVAILABLE VIGOR FAMILY OF PULSE GENERATORS AND ACCESSORIES, AND 2)A NEW MANUFACTURING CONTRACT FACILITY, EMD ASSOCIATES, INC., (EMD), 4065 THEURER BLVD., WINONA, MN 55987 |
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