PMA P030032S004
- Device
- HYLAFORM AND HYLAFORM PLUS
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S004
- Product code
- LMH
- Decision date
- 2005-11-02
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL FOR AN EXTENSION OF THE HYLAFORM AND HYLAFORM PLUS SHELF LIFE FROM 24 TO 36 MONTHS.
Current openFDA PMA Record#
- Device
- HYLAFORM AND HYLAFORM PLUS
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S004
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2005-11-02
- Decision code
- APPR
- Date received
- 2005-09-23
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR AN EXTENSION OF THE HYLAFORM AND HYLAFORM PLUS SHELF LIFE FROM 24 TO 36 MONTHS.