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 | CONFIENT, VIVIAN, INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY FAMILIES. |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S294 |
Date Received | 05/08/2013 |
Decision Date | 06/06/2013 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ALTERNATE STERILIZATION CYCLE TO REDUCE THE EVACUATION DWELL TIME DURING THE EO REMOVAL PHASE. |
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