Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceRadiesse (+) Lidocaine Dermal Filler
Generic Nameimplant, dermal, for aesthetic use
ApplicantMERZ NORTH AMERICA, INC
4133 courtney road
suite 10
franksville, WI 53126
PMA NumberP050052
Supplement NumberS100
Date Received10/24/2017
Decision Date11/21/2017
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 ProductYes
Approval Order Statement  
Change in the calcium hydroxylapatite particle component manufacturing throughput.
-
-