PMA P810002S122

Device: Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)
Applicant: ABBOTT MEDICAL
PMA number: P810002
Supplement: S122
Product code: LWQ
Decision date: 2024-08-15
Classification: Cardiovascular
Generic name: HEART-VALVE, MECHANICAL
Approval order statement: Approval for extending the shelf-life from 3-years to 5-years of the Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ)

Current openFDA PMA Record#

Device: Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)
Applicant: ABBOTT MEDICAL
PMA number: P810002
Supplement: S122
Product code: LWQ
Generic name: HEART-VALVE, MECHANICAL
Decision date: 2024-08-15
Decision code: APPR
Date received: 2024-05-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for extending the shelf-life from 3-years to 5-years of the Masters HP Valved Graft with Gelweave Valsalva™ Technology (VAVGJ)