PMA P030032S008
- Device
- HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL)
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S008
- Product code
- LMH
- Decision date
- 2010-02-24
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR A LABELING UPDATE TO CAPTIQUE AS A FOLLOW-UP TO THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- HYLAFORM FAMILY DERMAL FILLERS (HYLAFORM, HYLAFORM PLUS AND CAPTIQUE INJECTABLE GEL)
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S008
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2010-02-24
- Decision code
- APPR
- Date received
- 2009-04-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A LABELING UPDATE TO CAPTIQUE AS A FOLLOW-UP TO THE POST-APPROVAL STUDY.