BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-D
FDA premarket approval P010031/S408 · decided 2013-12-16
Approval details
- PMA number
- P010031
- Supplement
- S408
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D, VIVA S CRT-DAND VIVA XT- CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-11-18
- Decision date
- 2013-12-16
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- 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).
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