CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D, PROTECTA CRT-D, PROTECTA DF4
FDA premarket approval P010031/S332 · decided 2012-09-20
Approval details
- PMA number
- P010031
- Supplement
- S332
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D, PROTECTA CRT-D, PROTECTA DF4
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-08-23
- Decision date
- 2012-09-20
- Days to decision
- 28 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE ACCEPTANCE CRITERIA INSPECTION PROCESS FOR ALL DIE LOCATIONS ON ALL HYBRIDS.
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