|
Device | ENTRUST/INTRINSIC/MARQUIS/MAXIMO/MAXIMO II/PROTECTA/PROTECTA XT/SECURA/VIRTUOSO/VIRTUOSO II |
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 | S322 |
Date Received | 09/16/2011 |
Decision Date | 10/13/2011 |
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 SOFTWARE UPDATES FOR A TESTING APPLICATION. |