PMA P030032S001
- Device
- HYLAFORM PLUS (HYLAN B GEL)
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S001
- Product code
- LMH
- Decision date
- 2004-10-13
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR THE HYLAFORM PLUS. THE DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf3/P030032S001B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- HYLAFORM PLUS (HYLAN B GEL)
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S001
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2004-10-13
- Decision code
- APPR
- Date received
- 2004-06-22
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE HYLAFORM PLUS. THE DEVICE IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).