PMA P910023S412
- Device
- Fortify, Fortify Assura, Ellipse
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S412
- Product code
- LWS
- Decision date
- 2018-10-24
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Alternate supplier of 100% ethylene oxide gas for device sterilization.
Current openFDA PMA Record#
- Device
- Fortify, Fortify Assura, Ellipse
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S412
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-10-24
- Decision code
- OK30
- Date received
- 2018-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate supplier of 100% ethylene oxide gas for device sterilization.