BRAVA (CRT-D/QUAD),CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D,PROTECTA XT,VIVA QUAD (S/XT),VIVA (S/XT)
FDA premarket approval P010031/S490 · decided 2015-03-04
Approval details
- PMA number
- P010031
- Supplement
- S490
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA (CRT-D/QUAD),CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D,PROTECTA XT,VIVA QUAD (S/XT),VIVA (S/XT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-02-04
- Decision date
- 2015-03-04
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADD ALTERNATIVE ULTRAVIOLET (UV) IRRADIATOR EQUIPMENT IN THE MANUFACTURING PROCESS FOR THE DEVICES.
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