|
Device | CAPSURE/VITATRON CRYSTALINE/EXCELLENCE +/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 | S063 |
Date Received | 04/26/2011 |
Decision Date | 05/19/2011 |
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 | No |
Approval Order Statement USE OF MES WEB SERVICES; REPLACING THE PAPER LOGS WITH ELECTRONIC DATA LOGS; AND A MODIFICATION OF THE DEFAULT LOT SIZE IN NEW WORK ORDERS. |