|
Device | BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-D |
Applicant | MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P010031 |
Supplement Number | S408 |
Date Received | 11/18/2013 |
Decision Date | 12/16/2013 |
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 A NEW LASER WELDING STATION FOR THE BATTERY ELECTRICAL CONNECTION PROCESS AS WELL AS A CHANGE IN MANUFACTURING LOCATION FOR THE LASER WELDING PROCESS AND OPEN CIRCUIT VOLTAGE INSPECTION (OCV). |