BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D,
FDA premarket approval P010031/S515 · decided 2015-10-23
Approval details
- PMA number
- P010031
- Supplement
- S515
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D, VIVA QUAD S CRT-D,
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-09-30
- Decision date
- 2015-10-23
- Days to decision
- 23 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REMOVAL OF VARIOUS VISUAL INSPECTIONS AND RE-ORDERING OF STEPS IN THE WORK INSTRUCTIONS IMPLEMENTED IN THE AUTOMATIC LINE OF FINAL PACKAGING.
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