EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD, INTRINSIC ICD, MARQUIS ICD,MARQUIS V
FDA premarket approval P980016/S500 · decided 2014-11-07
Approval details
- PMA number
- P980016
- Supplement
- S500
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD, EVERA XT VR ICD, INTRINSIC 30 ICD, INTRINSIC ICD, MARQUIS ICD,MARQUIS V
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-08-27
- Decision date
- 2014-11-07
- Days to decision
- 72 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE SOFTWARE VERSION R67 OF MYCARELINK PATIENT MONITOR 24950 TO BE USED WITH THE DEVICES.
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