|
Device | CAPSURE EPI UNIPOLAR/BIOPOLAR LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC Inc. 8200 CORAL SEA STREET NE MS MV S11 MOUNDS VIEW, MN 55112 |
PMA Number | P950024 |
Supplement Number | S017 |
Date Received | 02/25/2009 |
Decision Date | 07/29/2011 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC PUERTO RICO OPERATIONS CO. IN VILLALBA, PUERTO RICO. |