|
Device | BRAVA/VIVA S/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 | S356 |
Date Received | 02/07/2013 |
Decision Date | 03/05/2013 |
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 (1) FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1; (2) MODIFICATION OF CONTROLLED ENVIRONMENT AREA; (3) NEW PRESSURE TESTER AT SMO FACILITY; AND (4) TEMPORARY GOWNING AREA AND TEMPORARY WALLS AND RELOCATION OF THE MILLING ROOM. |