|
Device | RESTYLANE INJECTABLE GEL |
Generic Name | Implant, dermal, for aesthetic use |
Applicant | Q-Med AB SEMINARIEGATAN 21 UPPSALA SE-75-752- |
PMA Number | P040024 |
Supplement Number | S026 |
Date Received | 06/27/2008 |
Decision Date | 07/15/2008 |
Product Code |
LMH |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE FOLLOWING CHANGES TO THE PRODUCT SPECIFICATIONS FOR THE PHOSPHATE BUFFER CONCENTRATE: 1) TO NARROW THE SPECIFICATION LIMIT FOR THE CONCENTRATION OF THE BUFFERING IONS IN THE PHOSPHATE BUFFER TO 23.4 ¿ 28.4 MG/ML FOR THE POTASSIUM DIHYDROGEN PHOSPHATE CONTENT AND TO 131-157 MG/ML FOR THE DISODIUM HYDROGEN PHOSPHATE CONTENT; 2) TO ADD THE BACTERIAL ENDOTOXIN TEST TO THE PHOSPHATE BUFFER CONCENTRATE SPECIFICATION; AND 3) TO ADD THE PH TEST TO THE PHOSPHATE BUFFER SPECIFICATION. |