CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES; MERLIN.NET SYSTEM AND MERLIN@HOME
FDA premarket approval P910023/S359 · decided 2015-09-03
Approval details
- PMA number
- P910023
- Supplement
- S359
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CURRENT+, FORTIFY, FORTIFY ASSURA AND ELLIPSE FAMILY OF ICD DEVICES; MERLIN.NET SYSTEM AND MERLIN@HOME
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-08-10
- Decision date
- 2015-09-03
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- USE OF AN AUTOMATED ENVIRONMENT MONITORING SYSTEM TO REPLACE EXISTING MANUAL CHART RECORDERS.
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