PMA P030032S002
- Device
- CAPTIQUE INJECTABLE GEL
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S002
- Product code
- LMH
- Decision date
- 2004-11-12
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR A NEW SOURCE OF HYALURONIC ACID OBTAINED FROM BACTERIAL FERMENTATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CAPTIQUE AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
Current openFDA PMA Record#
- Device
- CAPTIQUE INJECTABLE GEL
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S002
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2004-11-12
- Decision code
- APPR
- Date received
- 2004-07-28
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR A NEW SOURCE OF HYALURONIC ACID OBTAINED FROM BACTERIAL FERMENTATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CAPTIQUE AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).