CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S
FDA premarket approval P910023/S297 · decided 2014-04-10
Approval details
- PMA number
- P910023
- Supplement
- S297
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CADENCE/ELLIPSE/FORTIFY ASSURA FAMILY OF ICD'S
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-07-11
- Decision date
- 2014-04-10
- Days to decision
- 638 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MERLIN CONDUCT MOBILE SOFTWARE APPLICATION AND MODEL 3330 VERSION 16.1 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM FOR THE DEVICES.
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