|
Device | CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S279 |
Date Received | 11/04/2011 |
Decision Date | 11/30/2011 |
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 REMOVAL OF REJECTION CRITERIA AND ASSOCIATED RE-CLEAN PROCESS FOR FLUX BLEED-OUT ON RF MODULES. |