SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/PROTECTA DR/VR/PTOTECTA XT DR/VR/INSYNC II/III MARQUIS
FDA premarket approval P980016/S299 · decided 2011-05-26
Approval details
- PMA number
- P980016
- Supplement
- S299
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SECURA DR/VR/VIRTUOSO II DR/VR/MAXIMO II DR/VR/ENTRUST/VIRTUOSO/PROTECTA DR/VR/PTOTECTA XT DR/VR/INSYNC II/III MARQUIS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-04-29
- Decision date
- 2011-05-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- UPDATE TO PROCESS OPERATION DESCRIPTIONS AND THE IMPLEMENTATION OF NEW TEST MONITORING FOR PACKAGING.
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