Evera MRI, S DR, S VR, XT DR, XTVR ICD's; Maximo II ICD; Protecta VR, XT ICDs; Secura DR ICD's; Virtuose II DR/VR ICD; V
FDA premarket approval P980016/S606 · decided 2017-01-06
Approval details
- PMA number
- P980016
- Supplement
- S606
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Evera MRI, S DR, S VR, XT DR, XTVR ICD's; Maximo II ICD; Protecta VR, XT ICDs; Secura DR ICD's; Virtuose II DR/VR ICD; V
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-10-14
- Decision date
- 2017-01-06
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for minor changes to the printed wiring board.
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