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 | LINOX SMART SD, LINOX SMART TD, LINOX SMART S, LINOX SMART T, LINOX SMART S DX, VIGILA 1CR, VOLTA 1CR, KAINOX VCS,PROTEG |
Generic Name | Permanent defibrillator electrodes |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S061 |
Date Received | 09/19/2014 |
Decision Date | 10/10/2014 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement USE OF SUPPLEMENTAL STERILIZATION EQUIPMENT. |
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