|
Device | CAPSURE/VITATRON CRYSTALINE & EXCELLENCE PS+ |
Generic Name | Permanent defibrillator electrodes |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P830061 |
Supplement Number | S061 |
Date Received | 03/18/2011 |
Decision Date | 06/16/2011 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE SUPPLIER FOR THE STERILE BARRIER TRAYS AND CHANGE IN ORIENTATION OF TOOLING ID NUMBER ON THE TRAY. |