APPLICATION SOFTWARE, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD,GEM I
FDA premarket approval P980016/S537 · decided 2015-06-04
Approval details
- PMA number
- P980016
- Supplement
- S537
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- APPLICATION SOFTWARE, EVERA S DR ICD, EVERA S VR ICD, EVERA XT DR ICD,EVERA XT VR ICD,GEM DR ICD,GEM II DR ICD,GEM I
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-04-14
- Decision date
- 2015-06-04
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR AN UPGRADE TO THE BOMGAR SERVER AND ADDITION OFREDUNDANT REMOTE CONTROL BLOCKER SOFTWARE.
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