Evera, Maximo, Protecta, Secura, Visia MRI VR/XT/DR/AF ICD
FDA premarket approval P980016/S631 · decided 2017-05-15
Approval details
- PMA number
- P980016
- Supplement
- S631
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera, Maximo, Protecta, Secura, Visia MRI VR/XT/DR/AF ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-04-19
- Decision date
- 2017-05-15
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implementation of a hardness manufacturing process monitor for the backfill weld process used at final device manufacturing facilities.
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