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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMasters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ)
Generic NameHEART-VALVE, MECHANICAL
ApplicantABBOTT MEDICAL
177 County Rd. B E.
St. Paul, MN 55117
PMA NumberP810002
Supplement NumberS122
Date Received05/22/2024
Decision Date08/15/2024
Product Code LWQ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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)
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