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 | CAPSURE SP & CAPSURE Z |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P850089 |
Supplement Number | S056 |
Date Received | 06/27/2007 |
Decision Date | 07/27/2007 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement CHANGE IN THE MOLDING VENDOR FOR THE IS-1 CONNECTOR SLEEVE COMPONENT FROM MEDTRONIC PUERTO RICO OPERATIONS COMPANY TO FMI, INC. |
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