VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II VR/DR
FDA premarket approval P980016/S206 · decided 2010-02-03
Approval details
- PMA number
- P980016
- Supplement
- S206
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIRTUOSO II DR/VR/SECURA DR/VR/MAXIMO II VR/DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2009-09-21
- Decision date
- 2010-02-03
- Days to decision
- 135 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN MANUFACTURING TEST SOFTWARE AND TEST REQUIREMENTS.
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