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 | PUNCTUA CRT-D MODELS (N050, N051), ENERGEN CRT-D MODELS (N140, N141) INCEPTA CRT-D MODELS (N160, N161, N164) |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S282 |
Date Received | 02/09/2012 |
Decision Date | 03/15/2012 |
Product Code |
NIK |
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 MINOR DESIGN CHANGES AND ASSOCIATED MANUFACTURING CHANGES TO THE PUNCTUA/ INCEPTA/ ENERGEN HYBRID ASSEMBLY. |
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