|
Device | PROTECTA CRT-D, PROTECTA XT CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S291 |
Date Received | 02/13/2012 |
Decision Date | 03/09/2012 |
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 ADD ADDITIONAL MODELS THAT WERE NOT INCLUDED IN A PREVIOUSLY APPROVED 30-DAY NOTICE REGARDING THE IMPLEMENTATION OF MATERIAL ANALYSIS AND QUALIFICATION SYSTEM (MAQS) FOR INCOMING INSPECTION. |