PMA P810002S115
- Device
- Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S115
- Product code
- LWQ
- Decision date
- 2021-12-09
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Use of a new detergent in the manufacture of the valves cuff fabric component.
Current openFDA PMA Record#
- Device
- Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S115
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2021-12-09
- Decision code
- OK30
- Date received
- 2021-11-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Use of a new detergent in the manufacture of the valves cuff fabric component.