Evera S, Maximo II, Protecta, Secura,Quad XT CRT-D; Virtuoso II, Visia AF, MRI VR ICD,
FDA premarket approval P980016/S601 · decided 2016-10-04
Approval details
- PMA number
- P980016
- Supplement
- S601
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera S, Maximo II, Protecta, Secura,Quad XT CRT-D; Virtuoso II, Visia AF, MRI VR ICD,
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-09-15
- Decision date
- 2016-10-04
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Update to the manufacturing inspection process for feedthrough assemblies.
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