Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators
FDA premarket approval P980016/S635 · decided 2017-06-30
Approval details
- PMA number
- P980016
- Supplement
- S635
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-06-07
- Decision date
- 2017-06-30
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Software and hardware changes to the Titan Device Tester which is used during final functional device testing.
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