BRAVA/VIVA S/VIVA XT CRT-D
FDA premarket approval P010031/S356 · decided 2013-03-05
Approval details
- PMA number
- P010031
- Supplement
- S356
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA/VIVA S/VIVA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-02-07
- Decision date
- 2013-03-05
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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.
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