Arista AH Absorbable Hemostatic Particles

FDA Premarket Approval P050038 S039

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 replacement of an in vitro hemostasis specification and test method used for lot release testing.

DeviceArista AH Absorbable Hemostatic Particles
Generic NameAgent, Absorbable Hemostatic, Non-collagen Based
ApplicantDavol, Inc.
Date Received2021-05-24
Decision Date2021-08-20
Product CodeLMG 
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Davol, Inc. 100 Crossings Boulevard warwick, RI 02886

Supplemental Filings

Supplement NumberDateSupplement Type
P050038Original Filing
S039 2021-05-24 Real-time Process
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
S032 2018-08-01 135 Review Track For 30-day Notice
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
S013 2012-12-13 30-day Notice
S012 2012-12-10 30-day Notice
S011 2012-02-22 30-day Notice
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


Device IDPMASupp
10801741096805 P050038 023

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