|
Device | MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR/VIRTUOSO/ENTRUST/MARQUIS/MAXIMO/INTRINSIC ICDS |
Generic Name | Implantable cardioverter defibrillator (non-CRT) |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MS MVS11 MOUNDS VIEW, MN 55112 |
PMA Number | P980016 |
Supplement Number | S276 |
Date Received | 01/18/2011 |
Decision Date | 02/17/2011 |
Product Code |
LWS |
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 IMPLEMENTATION OF A DETECTION STEP IN THE BATTERY MANUFACTURING PROCESS AT A SUPPLIER. |