Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne
FDA premarket approval P910023/S428 · decided 2020-09-22
Approval details
- PMA number
- P910023
- Supplement
- S428
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2020-07-07
- Decision date
- 2020-09-22
- Days to decision
- 77 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for a shelf-life extension from 6-months to 24-months for Avant, Gallant, Entrant, and Neutrino NxT" Family of ICDs and CRT-Ds.
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