PMA P910023S351
- Device
- FORTIFY VR,FORTIFY DR,FORTIFY ASSURA VR, FORTIFY ASSURA DR ICDS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S351
- Product code
- LWS
- Decision date
- 2015-01-28
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR MODIFIED DESIGN OF INSULATING TAPE.
Current openFDA PMA Record#
- Device
- FORTIFY VR,FORTIFY DR,FORTIFY ASSURA VR, FORTIFY ASSURA DR ICDS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S351
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2015-01-28
- Decision code
- APPR
- Date received
- 2014-12-08
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR MODIFIED DESIGN OF INSULATING TAPE.