PMA P810002S118
- Device
- Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S118
- Product code
- LWQ
- Decision date
- 2023-03-31
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- Supplier change to resin material for use in manufacturing the sewing cuff fabric of the VAVGJ valved conduit.
Current openFDA PMA Record#
- Device
- Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S118
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2023-03-31
- Decision code
- OK30
- Date received
- 2023-03-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Supplier change to resin material for use in manufacturing the sewing cuff fabric of the VAVGJ valved conduit.