MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
FDA premarket approval P980016/S368 · decided 2012-08-14
Approval details
- PMA number
- P980016
- Supplement
- S368
- Supplement type
- 30-Day Notice
- Trade name
- MAXIMO II DF4 CRT-D, DF4 ICD, ICD, SECURA DF4 ICD, SECURA ICD, VIRTUOSO II DR/VR ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-07-19
- Decision date
- 2012-08-14
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATES TO THE HYBRID TESTING PROCESS.
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