BRAVA , QUAD , VIVA QUAD S CRT-D'S; VIVA QUAD S , QUAD XT, S VIVA S CRT-D'S
FDA premarket approval P010031/S486 · decided 2015-02-26
Approval details
- PMA number
- P010031
- Supplement
- S486
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA , QUAD , VIVA QUAD S CRT-D'S; VIVA QUAD S , QUAD XT, S VIVA S CRT-D'S
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-01-28
- Decision date
- 2015-02-26
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE TO THE MANUFACTURING PROCESS AND SPECIFICATION OF TANTALUM PINS.
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