MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR/VIRTUOSO/ENTRUST/MARQUIS/MAXIMO/INTRINSIC ICDS
FDA premarket approval P980016/S276 · decided 2011-02-17
Approval details
- PMA number
- P980016
- Supplement
- S276
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MAXIMO II DR/VR/VIRTUOSO II DR/VR/SECURA DR/VR/VIRTUOSO/ENTRUST/MARQUIS/MAXIMO/INTRINSIC ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-01-18
- Decision date
- 2011-02-17
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- IMPLEMENTATION OF A DETECTION STEP IN THE BATTERY MANUFACTURING PROCESS AT A SUPPLIER.
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