|
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 | S066 |
Date Received | 06/08/2011 |
Decision Date | 11/18/2011 |
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 | Yes |
Approval Order Statement APPROVAL FOR UPDATES TO THE STERILE PACKAGING ASSEMBLY PROCESS FOR NEW AND EXISTING SEALER EQUIPMENT. |