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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.
 
DeviceBelotero Balance (+) Lidocaine
Generic NameImplant, dermal, for aesthetic use
ApplicantMerz North America, Inc.
4133 Ct.ney Rd., Suite 10
Franksville, WI 53126
PMA NumberP090016
Supplement NumberS049
Date Received07/21/2022
Decision Date10/26/2022
Product Code LMH 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval to increase the tolerance range for the lidocaine hydrochloride specification from 3.00 ± 5% mg/mL (2.85-3.15 mg/mL) to 3.0 ± 10% mg/mL (2.7 - 3.3 mg/mL).
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