• 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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameimplant, dermal, for aesthetic use
Generic Nameimplant, dermal, for aesthetic use
55 cambridge parkway
cambridge, MA 02142
PMA NumberP030032
Supplement NumberS012
Date Received05/27/2011
Decision Date07/18/2011
Product Code
LMH[ Registered Establishments with LMH ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for changes in the methods and specifications for testing the prevelle silk final product (i. E. , 1) changing the average extrusion force specificationfrom less than 80n to an average of average extrusion force specification of less than 40n, 2) changing the maximum peak extrusion force specification of less than 100n to an average of maximum peak extrusion force" specification of less than 50n and 3) changing the method of determining the maximum peak extrusion force specification from the highest single value observed in 10 samples to an average of the maximum peak extrusion force test results observed in 25 samples).