Arista AH Absorbable Hemostatic Particles

FDA Premarket Approval P050038 S037

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 an additional filling and packaging site for the arista ah absorbable hemostatic device at the davol, inc. Woburn, massachusetts manufacturing site

DeviceArista AH Absorbable Hemostatic Particles
Generic NameAgent, Absorbable Hemostatic, Non-collagen Based
ApplicantDavol, Inc.
Date Received2020-10-02
Decision Date2021-07-06
PMAP050038
SupplementS037
Product CodeLMG 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonLocation Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Davol, Inc. 100 Crossings Boulevard warwick, RI 02886

Supplemental Filings

Supplement NumberDateSupplement Type
P050038Original Filing
S037 2020-10-02 Normal 180 Day Track No User Fee
S036 2020-08-26 Special (immediate Track)
S035 2020-02-24 Real-time Process
S034 2019-10-21 30-day Notice
S033
S032 2018-08-01 135 Review Track For 30-day Notice
S031
S030 2016-06-17 Normal 180 Day Track
S029 2016-02-23 30-day Notice
S028 2015-12-09 30-day Notice
S027 2015-11-02 30-day Notice
S026 2015-08-10 30-day Notice
S025 2015-07-02 30-day Notice
S024 2015-05-27 30-day Notice
S023 2014-07-29 Normal 180 Day Track
S022 2014-04-29 Normal 180 Day Track No User Fee
S021 2014-02-19 30-day Notice
S020 2014-02-11 30-day Notice
S019 2013-12-13 Real-time Process
S018 2013-05-31 30-day Notice
S017 2013-04-08 Normal 180 Day Track No User Fee
S016 2013-03-07 30-day Notice
S015 2013-02-22 30-day Notice
S014
S013 2012-12-13 30-day Notice
S012 2012-12-10 30-day Notice
S011 2012-02-22 30-day Notice
S010
S009
S008 2008-08-29 30-day Notice
S007 2008-06-17 Normal 180 Day Track No User Fee
S006 2008-06-03 30-day Notice
S005 2008-05-09 Normal 180 Day Track No User Fee
S004 2007-11-16 Normal 180 Day Track No User Fee
S003 2007-08-30 30-day Notice
S002 2007-05-07 Normal 180 Day Track No User Fee
S001 2007-05-01 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
10801741096805 P050038 023

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