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Device | VIGILA AND VOLTA AND PASSIVE FIXATION BIPOLAR STEROID ELUTING ICD LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S046 |
Date Received | 11/14/2011 |
Decision Date | 02/22/2012 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR THE FOLLOWING: 1) ADDITION OF TRADE NAMES VIGILA AND VOLTA FOR THE LINOX AND LINOX SMART DEFIBRILLATION LEADS; 2) CHANGE TO INDICATIONS FOR USE STATEMENT TO CLARIFY THAT THE VIGILA AND VOLTA LEADS MAYBE USED WITH ANY MANUFACTURERS' ICDS; AND 3) ACCESSORY KITS FOR USE WITH THE VIGILA AND VOLTA LEADS. |
Approval Order | Approval Order |