PMA P030032S005
- Device
- HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S005
- Product code
- LMH
- Decision date
- 2006-02-28
- Generic name
- Implant, dermal, for aesthetic use
- Approval order statement
- APPROVAL OF A CLARIFICATION OF THE DEFINITION OF SERIOUS ADVERSE EVENTS.
Current openFDA PMA Record#
- Device
- HYLAFORM (HYLAN B GEL), HYLAFORM PLUS, CAPTIQUE
- Applicant
- Genzyme Biosurgery
- PMA number
- P030032
- Supplement
- S005
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2006-02-28
- Decision code
- APPR
- Date received
- 2006-01-27
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF A CLARIFICATION OF THE DEFINITION OF SERIOUS ADVERSE EVENTS.