PMA P810002S123
- Device
- Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S123
- Product code
- LWQ
- Decision date
- 2024-07-02
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- a change in manufacturing of the Tyvek Lids for the inner and outer trays in the packaging system
Current openFDA PMA Record#
- Device
- Masters Series™ Aortic Valved Graft with Hemashield Graft Technology (CAVGJ)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S123
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2024-07-02
- Decision code
- OK30
- Date received
- 2024-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in manufacturing of the Tyvek Lids for the inner and outer trays in the packaging system