PMA P030032S007

Device: PREVELLE SILK
Applicant: Genzyme Biosurgery
PMA number: P030032
Supplement: S007
Product code: LMH
Decision date: 2008-02-26
Generic name: Implant, dermal, for aesthetic use
Approval order statement: APPROVAL FOR THE ADDITION OF PHOSPHATE BUFFERED SALINE (PBS) AND LIDOCAINE HYDROCHLORIDE (HCL). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PREVELLE SILK AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).

Current openFDA PMA Record#

Device: PREVELLE SILK
Applicant: Genzyme Biosurgery
PMA number: P030032
Supplement: S007
Product code: LMH
Generic name: Implant, dermal, for aesthetic use
Decision date: 2008-02-26
Decision code: APPR
Date received: 2007-07-25
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF PHOSPHATE BUFFERED SALINE (PBS) AND LIDOCAINE HYDROCHLORIDE (HCL). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PREVELLE SILK AND IS INDICATED FOR INJECTION INTO THE MID TO DEEP DERMIS FOR CORRECTION OF MODERATE TO SEVERE FACIAL WRINKLES AND FOLDS (SUCH AS NASOLABIAL FOLDS).