HYDRELLE

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P050033

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the cosmetic tissue augmentation product. This 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).

• Device: HYDRELLE
• Classification Name: Implant, Dermal, For Aesthetic Use
• Generic Name: Implant, Dermal, For Aesthetic Use
• Applicant: Anika Therapeutics, Inc.
• Date Received: 2005-09-02
• Decision Date: 2006-12-20
• Notice Date: 2006-12-26
• PMA: P050033
• Supplement: S
• Product Code: LMH
• Docket Number: 06M-0531
• Advisory Committee: General & Plastic Surgery
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P050033		Original Filing
S020	2015-09-29	Special (immediate Track)
S019	2015-03-12	30-day Notice
S018	2015-01-29	135 Review Track For 30-day Notice
S017	2014-05-01	30-day Notice
S016	2014-05-01	Real-time Process
S015	2012-05-04	135 Review Track For 30-day Notice
S014	2011-12-23	Special (immediate Track)
S013	2011-06-20	Normal 180 Day Track No User Fee
S012	2011-04-12	135 Review Track For 30-day Notice
S011	2010-11-03	30-day Notice
S010
S009	2010-08-04	Special (immediate Track)
S008	2009-09-08	Special (immediate Track)
S007	2009-05-15	Normal 180 Day Track No User Fee
S006	2009-02-18	Normal 180 Day Track No User Fee
S005	2007-09-19	Normal 180 Day Track No User Fee
S004	2007-09-17	Real-time Process
S003	2007-09-06	135 Review Track For 30-day Notice
S002	2007-05-31	Normal 180 Day Track No User Fee
S001	2007-01-03	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00866142000014	P050033	000
00866142000007	P050033	000