RESTYLANE INJECTABLE GEL
FDA premarket approval P040024/S026 · decided 2008-07-15
Approval details
- PMA number
- P040024
- Supplement
- S026
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESTYLANE INJECTABLE GEL
- Generic name
- Implant, dermal, for aesthetic use
- Applicant
- Q-Med AB
- Date received
- 2008-06-27
- Decision date
- 2008-07-15
- Days to decision
- 18 days
- Decision code
- APPR
- Product code
- LMH
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Uppsala
- 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 SP
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.