Avitene Microfibrillar Collagen Hemostat

FDA Premarket Approval P800002 S028

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

Changes to the secondary pouch material and supplier facility for avitene microfibrillar collagen hemostat

DeviceAvitene Microfibrillar Collagen Hemostat
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantC.R. Bard, Inc.
Date Received2021-01-19
Decision Date2021-02-17
PMAP800002
SupplementS028
Product CodeLMF 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address C.R. Bard, Inc. 160 New Boston Street woburn, MA 01801

Supplemental Filings

Supplement NumberDateSupplement Type
P800002Original Filing
S028 2021-01-19 30-day Notice
S027
S026 2020-02-28 30-day Notice
S025 2019-05-20 30-day Notice
S024 2018-12-03 30-day Notice
S023 2018-06-28 30-day Notice
S022 2017-03-27 135 Review Track For 30-day Notice
S021 2014-05-30 30-day Notice
S020 2013-12-11 30-day Notice
S019 2013-06-24 30-day Notice
S018 2011-12-22 Special (immediate Track)
S017 2011-09-02 30-day Notice
S016 2009-03-20 30-day Notice
S015 2005-09-08 30-day Notice
S014 2004-10-04 30-day Notice
S013 2003-06-11 30-day Notice
S012 2001-05-23 30-day Notice
S011 1998-07-21 30-day Notice
S010 1993-12-02 Normal 180 Day Track
S009 1992-01-21 Normal 180 Day Track
S008 1991-10-16 Normal 180 Day Track
S007 1988-03-08 Normal 180 Day Track
S006
S005 1983-10-11
S004 1983-08-30
S003 1982-01-07
S002 1981-01-27
S001 1981-04-09

NIH GUDID Devices

Device IDPMASupp
10801741010450 P800002 001
10801741010467 P800002 001
10801741010474 P800002 001
10801741010467 P800002 001
10801741010450 P800002 001
10801741010474 P800002 001
10801741010481 P800002 008
10801741010498 P800002 008
10801741010481 P800002 008
10801741010498 P800002 008

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