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/S426 · decided 2014-03-04
Approval details
- PMA number
- P010031
- Supplement
- S426
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2014-02-14
- Decision date
- 2014-03-04
- Days to decision
- 18 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REPLACEMENT OF TWO (2) PICK AND PLACE MACHINES WITH ONE (1) NEW SYSTEM USED IN HYBRID MANUFACTURING FOR THE IDENTIFIED DEVICES.
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