|
Device | BRAVA CRT-D ; CONCERTO II CRT-D; CONSULTA ICD; MAXIMO II CRT-D; PROTECTA CRT-D; PROTECTA XT CRT-D; VIVA S CRT-D; XT CRT- |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S445 |
Date Received | 05/08/2014 |
Decision Date | 05/30/2014 |
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 CHANGE IN THE AVX CAPACITOR LAPPING PROCESS USED IN THE DEVICES. |