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 | TELIGEN, INCEPTA, ENERGEN AND PUNCTUA ICD DEVICES |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960040 |
Supplement Number | S270 |
Date Received | 08/28/2012 |
Decision Date | 11/30/2012 |
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 |
Review Memo | Review Memo |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR SOFTWARE, FIRMWARE, AND HARDWARE ENHANCEMENTS AND MODIFICATIONS TO THE INCEPTA, ENERGEN, PUNCTUA, COGNIS, AND TELIGEN DEVICES. |
Approval Order | Approval Order |
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