EVERA S DR ICD. EVERA S VR ICD, EVERA XT DR ICD; EVERA XT VR ICD, PROTECTA ICD, PROCTECTA XT ICD
FDA premarket approval P980016/S435 · decided 2013-10-31
Approval details
- PMA number
- P980016
- Supplement
- S435
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- EVERA S DR ICD. EVERA S VR ICD, EVERA XT DR ICD; EVERA XT VR ICD, PROTECTA ICD, PROCTECTA XT ICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-08-15
- Decision date
- 2013-10-31
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR LABELING UPDATES FOR THE DEVICES.
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