HYLAFORM PLUS (HYLAN B GEL)

FDA Premarket Approval P030032 S001

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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).

DeviceHYLAFORM PLUS (HYLAN B GEL)
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantGENZYME BIOSURGERY
Date Received2004-06-22
Decision Date2004-10-13
Notice Date2004-10-27
PMAP030032
SupplementS001
Product CodeLMH 
Docket Number04M-0467
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypePanel Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address GENZYME BIOSURGERY 55 Cambridge Parkway cambridge, MA 02142
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P030032Original Filing
S017 2014-08-08 30-day Notice
S016 2013-09-25 135 Review Track For 30-day Notice
S015
S014 2011-12-20 135 Review Track For 30-day Notice
S013 2011-09-02 30-day Notice
S012 2011-05-27 Real-time Process
S011
S010 2010-06-09 135 Review Track For 30-day Notice
S009 2009-09-11 30-day Notice
S008 2009-04-15 Normal 180 Day Track No User Fee
S007 2007-07-25 Normal 180 Day Track
S006
S005 2006-01-27 Normal 180 Day Track No User Fee
S004 2005-09-23 Real-time Process
S003 2005-04-20 Normal 180 Day Track No User Fee
S002 2004-07-28 Normal 180 Day Track
S001 2004-06-22 Panel Track

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