EVERA MRI, S DR ,S VR, XT DR , XT VR ICD'S; MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR
FDA premarket approval P980016/S589 · decided 2016-05-25
Approval details
- PMA number
- P980016
- Supplement
- S589
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EVERA MRI, S DR ,S VR, XT DR , XT VR ICD'S; MAXIMO II ICD; PROTECTA ICD, PROTECTA XT ICD; SECURA ICD; VIRTUOSO II DR/VR
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-05-03
- Decision date
- 2016-05-25
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Changes to the wafer manufacturing process.
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