EVERA MRI; EVERA S DR;EVERA XT DR; EVERA XT VR; MAXIMO II; PROTECTA; PROTECTA XT; SECURA ICDS
FDA premarket approval P980016/S565 · decided 2016-03-10
Approval details
- PMA number
- P980016
- Supplement
- S565
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EVERA MRI; EVERA S DR;EVERA XT DR; EVERA XT VR; MAXIMO II; PROTECTA; PROTECTA XT; SECURA ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-01-11
- Decision date
- 2016-03-10
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for the addition of a passivation layer to the XD429 component used in the hybrid charging circuit and the associated manufacturing changes.
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