BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD S
FDA premarket approval P010031/S484 · decided 2015-02-19
Approval details
- PMA number
- P010031
- Supplement
- S484
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, XT CRT-D, VIVA QUAD S
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-01-23
- Decision date
- 2015-02-19
- Days to decision
- 27 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- AUTOMATION OF A VISUAL INSPECTION OF THE CONNECTOR ASSEMBLY.
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