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 | STELID II BFT/BJF/STELIX BR/STELIX II BRF |
Generic Name | Permanent defibrillator electrodes |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P020030 |
Supplement Number | S009 |
Date Received | 01/27/2012 |
Decision Date | 02/16/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement CLEAN ROOM LAYOUT MODIFICATIONS OF SALUGGIA, ITALY PLANT. |
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