PMA P910023S445
- Device
- Implantable Cardioverter Defibrillators
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S445
- Product code
- LWS
- Decision date
- 2022-06-22
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add Abbott Medical as an alternate supplier for header components used in Abbott ICD devices.
Current openFDA PMA Record#
- Device
- Implantable Cardioverter Defibrillators
- Applicant
- ABBOTT MEDICAL
- PMA number
- P910023
- Supplement
- S445
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2022-06-22
- Decision code
- OK30
- Date received
- 2022-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add Abbott Medical as an alternate supplier for header components used in Abbott ICD devices.