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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.
 
DeviceUltra, Ultra XC, Ultra Plus XC
Generic NameImplant, dermal, for aesthetic use
ApplicantAllergan
2525 Dupont Dr.
Irvine, CA 92612
PMA NumberP050047
Supplement NumberS096
Date Received08/05/2024
Decision Date09/04/2024
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for extending the shelf-life of the 1.0mL empty syringe from 24 months to 36 months
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