PMA P910023S407
- Device
- Forify, Fortify Assura
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S407
- Product code
- LWS
- Decision date
- 2018-04-03
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Use of a plastic ring frame as an alternative to a ceramic frame in hybrids.
Current openFDA PMA Record#
- Device
- Forify, Fortify Assura
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S407
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-04-03
- Decision code
- OK30
- Date received
- 2018-03-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a plastic ring frame as an alternative to a ceramic frame in hybrids.