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 | SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD) SYSTEM, Q-GUIDE ELECTRODE INSERTION TOOL |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | BOSTON SCIENTIFIC CORPORATION 4100 HAMLINE AVENUE NORTH ST. PAUL, MN 55112-5798 |
PMA Number | P110042 |
Supplement Number | S033 |
Date Received | 05/05/2014 |
Decision Date | 05/28/2014 |
Product Code |
LWS |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement TRANSFER THE FINAL PACKAGE FOR THE EIT FROM CAMERON TO CAMERONS CONTRACT MANUFACTURER BOSTON SCIENTIFIC CORPORATION (BSC). |
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