CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+, FAMILY OF ICDS
FDA premarket approval P910023/S362 · decided 2016-05-12
Approval details
- PMA number
- P910023
- Supplement
- S362
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CURRENT, CURRENT ACCEL, CURRENT+, ELLIPSE, FORTIFY, FORTIFY ASSURA, EPIC/EPIC+, ATLAS/II/+, FAMILY OF ICDS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-09-15
- Decision date
- 2016-05-12
- Days to decision
- 240 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.
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