PMA P910023S375
- Device
- FORTIFY ASSURA VR, FORTIFY ASSURA DR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S375
- Product code
- LWS
- Decision date
- 2016-09-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for a minor design modification to the vibratory patient notifier.
Current openFDA PMA Record#
- Device
- FORTIFY ASSURA VR, FORTIFY ASSURA DR
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S375
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2016-09-06
- Decision code
- APPR
- Date received
- 2016-07-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a minor design modification to the vibratory patient notifier.