BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D
FDA premarket approval P010031/S374 · decided 2013-05-14
Approval details
- PMA number
- P010031
- Supplement
- S374
- Supplement type
- 30-Day Notice
- Trade name
- BRAVA CRT-D,CONCERTO II CRT-D,CONSULTA ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROTECTA XT CRT-D,VIVA S CRT-D,VIVA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-04-23
- Decision date
- 2013-05-14
- Days to decision
- 21 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- BUTTED CONTACT ETCH TIME CHANGE FOR THE M016 AND M017 INTEGRATED CIRCUITS.
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