VIRTUOSO DR, VIRTUOSO VR, SECURA DR AND MAXIMO II DR
FDA premarket approval P980016/S398 · decided 2014-04-23
Approval details
- PMA number
- P980016
- Supplement
- S398
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VIRTUOSO DR, VIRTUOSO VR, SECURA DR AND MAXIMO II DR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-02-21
- Decision date
- 2014-04-23
- Days to decision
- 426 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT PLEXUS(HANGZHOU) CO., LTD., IN HANGZHOU, ZHEJIANG, CHINA.
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