|
Device | EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD |
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 | S446 |
Date Received | 11/18/2013 |
Decision Date | 12/16/2013 |
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 |
Recalls | CDRH Recalls |
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). |