PMA P910023S331
- Device
- ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S331
- Product code
- LWS
- Decision date
- 2014-06-20
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR A CHANGE TO THE INTEGRATED CIRCUIT USED IN THE MANUFACTURING OF THE ICDS AND CRT-DS.
Current openFDA PMA Record#
- Device
- ELLIPSE, FORTIFY, FORTIFY ASSURA FAMILIES OF ICD
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S331
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-06-20
- Decision code
- APPR
- Date received
- 2014-02-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE INTEGRATED CIRCUIT USED IN THE MANUFACTURING OF THE ICDS AND CRT-DS.