EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT
FDA premarket approval P980016/S414 · decided 2013-05-14
Approval details
- PMA number
- P980016
- Supplement
- S414
- Supplement type
- 30-Day Notice
- Trade name
- EVERA S DR ICD,EVERA S VR ICD,EVERA XT DR ICD,EVERA XT VR ICD,MAXIMO II ICD,PROTECTA ICD,PROTECTA XT ICD,SECURA ICD,VIRT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2013-04-23
- Decision date
- 2013-05-14
- Days to decision
- 21 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- BUTTED CONTACT ETCH TIME CHANGE FOR THE M016 AND M017 INTEGRATED CIRCUITS.
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