CONCERTO ICD, CONCERTO II CRT-D & DF4 ICD, CONSULTA ICD, INSYNC II MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D
FDA premarket approval P010031/S342 · decided 2012-12-20
Approval details
- PMA number
- P010031
- Supplement
- S342
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO ICD, CONCERTO II CRT-D & DF4 ICD, CONSULTA ICD, INSYNC II MARQUIS ICD, INSYNC MAXIMO ICD, MAXIMO II CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-11-21
- Decision date
- 2012-12-20
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF THE MANUFACTURING EXECUTION SYSTEM VERSION 7.9 AT VARIOUS INTERNAL SUPPLIERS AND FINAL DEVICE MANUFACTURING LOCATIONS.
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