PMA P030032S003

Device
HYLAFORM, HYLAFORM PLUS, ND CAPTIQUE
Applicant
Genzyme Biosurgery
PMA number
P030032
Supplement
S003
Product code
LMH
Decision date
2005-07-01
Generic name
Implant, dermal, for aesthetic use
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.

Current openFDA PMA Record#

Device
HYLAFORM, HYLAFORM PLUS, ND CAPTIQUE
Applicant
Genzyme Biosurgery
PMA number
P030032
Supplement
S003
Product code
LMH
Generic name
Implant, dermal, for aesthetic use
Decision date
2005-07-01
Decision code
APPR
Date received
2005-04-20
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.