|
Device | RADIESSE INJECTABLE IMPLANT |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | MERZ NORTH AMERICA, INC 4133 COURTNEY ROAD SUITE 10 FRANKSVILLE, WI 53126 |
PMA Number | P050052 |
Supplement Number | S018 |
Date Received | 12/09/2008 |
Decision Date | 02/03/2009 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR: 1. CHANGING THE FILL VOLUME FROM A MAXIMUM DELIVERABLE FILL VOLUME OF 1.3 CC TO A MAXIMUM DELIVERABLE FILL VOLUME OF 1.5 CC.2. CHANGING THE SYRINGE BARREL HANDLE FROM A MOLDED STRAIGHT HANDLE TO A MOLDED HANDLE WITH AN ERGONOMIC CURVED HANDLE.3. MODIFICATION TO THE INSTRUCTION FOR USE TO INCLUDE THE 1.5 CC FILL VOLUME IN THE DEVICEDESCRIPTION SECTION OF THE INSTRUCTIONS FOR USE.4. CREATION OF PACKAGE LABELING SPECIFIC TO THE 1.5 CC FILL VOLUME, IDENTICAL TO THE PACKAGE LABELING FOR THE 0.3 CC AND 1.3 CC FILL VOLUME PRODUCTS WITH THE EXCEPTION OF THE IDENTIFIED FILL VOLUME AND PART NUMBER. |