PMA P020023
- Device
- RESTYLANE INJECTABLE GEL
- Applicant
- Q-Med AB
- PMA number
- P020023
- Product code
- LMHÂ
- Decision date
- 2003-12-12
- Generic name
- Implant, Dermal, For Aesthetic Use
- Approval order statement
- APPROVAL FOR THE RESTYLANE INJECTABLE GEL. THE DEVICE IS INDICATED FOR MID-TO-DEEP DERMAL IMPLANTATION FOR THE CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS, SUCH AS NASOLABIAL FOLDS.
- Summary
- Summary of Safety and Effectiveness
Current openFDA PMA Record
- Device
- RESTYLANE
- Applicant
- Q-Med AB
- PMA number
- P020023
- Supplement
- S012
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2005-10-21
- Decision code
- APPR
- Date received
- 2005-06-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR PERFORMING THE PROTEIN TESTING IN-HOUSE AT THE Q-MED QUALITY CONTROL LABORATORY AND TO CHANGE THE TEST METHOD SO AS TO ALLOW FOR THE DETECTION OF LOWER AMOUNTS OF PROTEIN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME RESTYLANE AND IS INDICATED AS AN INJECTABLE GEL FOR AESTHETIC USE.