CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROT
FDA premarket approval P010031/S380 · decided 2013-06-26
Approval details
- PMA number
- P010031
- Supplement
- S380
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO ICD,CONCERTO II CRT-D,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,MAXIMO II CRT-D,PROTECTA CRT-D,PROT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-05-29
- Decision date
- 2013-06-26
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- ADDITION OF A NEW PRESS FOR THE PIN INSERTION OPERATION.
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