CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES
FDA premarket approval P910023/S345 · decided 2014-10-21
Approval details
- PMA number
- P910023
- Supplement
- S345
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CURRENT, CURRENT ACCEL, CURRENT+, CURRENT RF, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD DEVICES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2014-09-26
- Decision date
- 2014-10-21
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- ALTERNATE SUPPLIER FOR THE HIGH VOLTAGE (HV) RF MODULES UTILIZED IN THE DEVICES ONLY.
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