Viva Quad XT CRTD, Viva XT CRT-D, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI DF-1 I
FDA premarket approval P980016/S869 · decided 2023-11-02
Approval details
- PMA number
- P980016
- Supplement
- S869
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Viva Quad XT CRTD, Viva XT CRT-D, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI DF-1 I
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2023-10-23
- Decision date
- 2023-11-02
- Days to decision
- 10 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- to implement a manufacturing change at the Medtronic Energy and Component Center (MECC)
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