Arista AH Absorbable Hemostatic Particles

FDA Premarket Approval P050038 S035

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 a change to the instructions for use on the cardiotomy filter size range to include a 20-40 micron size range for autologous blood salvage systems compatible with the device.

DeviceArista AH Absorbable Hemostatic Particles
Generic NameAgent, Absorbable Hemostatic, Non-collagen Based
ApplicantDavol, Inc.
Date Received2020-02-24
Decision Date2020-04-29
PMAP050038
SupplementS035
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
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
10801741096805 P050038 023

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