|
Device | CAPSURE LEAD, VITATRON CRYSTALINE LEAD, VITATRON EXCELLENCE PS+ LEAD |
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 | S088 |
Date Received | 03/22/2013 |
Decision Date | 04/11/2013 |
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 AUTOMATION OF THE DESTRUCTIVE TEST ANALYSIS FOR MONITORED PROCESSES. |