HYDRELLE

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P050033 S020

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 labeling modifications, as requested in fdas letter to manufacturers marketing soft tissue filler implants about the risks associated with vascular injection.

DeviceHYDRELLE
Classification NameImplant, Dermal, For Aesthetic Use
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantAnika Therapeutics, Inc.
Date Received2015-09-29
Decision Date2015-10-22
PMAP050033
SupplementS020
Product CodeLMH
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeSpecial (immediate Track)
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address Anika Therapeutics, Inc. 32 Wiggins Avenue bedford, MA 01730

Supplemental Filings

Supplement NumberDateSupplement Type
P050033Original 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 IDPMASupp
00866142000014 P050033 000
00866142000007 P050033 000

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