|
Device | VITATRON CRYSTALINE/EXCELLENCE +/PS+/CAPSURE SP/CAPSURE SENSE/CAPSURE SP NOVUS/CAPSURE LEAD DRUG COMBINATION |
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 | S059 |
Date Received | 11/12/2010 |
Decision Date | 12/08/2010 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement UPDATE TO SUPPLIER QUALITY SOFTWARE. |