BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAX
FDA premarket approval P010031/S367 · decided 2013-04-04
Approval details
- PMA number
- P010031
- Supplement
- S367
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D,VIVA S CRT-D,VIVA XT CRT-D,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAX
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-03-11
- Decision date
- 2013-04-04
- Days to decision
- 24 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES TO LOT RELEASE TESTING AND ACCEPTANCE OF DEVICE COMPONENTS.
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