COSMETIC TISSUE AUGMENTATION PRODUCT

Implant, Dermal, For Aesthetic Use

FDA Premarket Approval P050033 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: 1) an increase n the buffer concentration of the final product from 12 mm to 50 mm sodium phosphate; 2) the introduction of an antioxidant, i. E. , 0. 1% sodium metabisulfite, into the final product; and 3) the introduction of an 0. 5 ml configuration of cosmetic tissue augmentation product (cta).

DeviceCOSMETIC TISSUE AUGMENTATION PRODUCT
Classification NameImplant, Dermal, For Aesthetic Use
Generic NameImplant, Dermal, For Aesthetic Use
ApplicantAnika Therapeutics, Inc.
Date Received2007-01-03
Decision Date2007-07-16
PMAP050033
SupplementS001
Product CodeLMH
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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