PMA P910023S325
- Device
- FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S325
- Product code
- LWS
- Decision date
- 2014-02-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE IN THE HYDROHONE PROCESS.
Current openFDA PMA Record#
- Device
- FORTIFY, FORTIFY ASSURA, AND ELLIPSE ICD'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S325
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-02-06
- Decision code
- OK30
- Date received
- 2014-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE HYDROHONE PROCESS.