|
Device | PERLANE L INJACTABLE GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S054 |
Date Received | 07/21/2011 |
Decision Date | 08/18/2011 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement NEW FILL VOLUME FOR THE DEVICE AND A NEW NEEDLE SIZE TO BE USED WITH THE NEW FILL VOLUME. |
Post-Approval Study | Show Report Schedule and Study Progress |