CONCERTO II, CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D
FDA premarket approval P010031/S330 · decided 2012-09-05
Approval details
- PMA number
- P010031
- Supplement
- S330
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II, CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-08-08
- Decision date
- 2012-09-05
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF FACTORY WORKS RELEASE 8.0 AND MES WEB SERVICES RELEASE 2.1.
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