Avitene Microfibrillar Collagen Hemostat

FDA Premarket Approval N17600 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

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

DeviceAvitene Microfibrillar Collagen Hemostat
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantDAVOL, INC., SUB. C.R. BARD, INC.
Date Received2021-01-19
Decision Date2021-02-17
PMAN17600
SupplementS035
Product CodeLMF 
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address DAVOL, INC., SUB. C.R. BARD, INC. 100 Crossings Boulevard warwick, RI 02886

Supplemental Filings

Supplement NumberDateSupplement Type
N17600Original Filing
S035 2021-01-19 30-day Notice
S034
S033 2020-02-28 30-day Notice
S032 2019-05-20 30-day Notice
S031 2018-12-03 30-day Notice
S030 2018-06-28 30-day Notice
S029 2014-05-30 30-day Notice
S028 2013-06-24 30-day Notice
S027 2013-05-28 30-day Notice
S026 2011-12-22 Special (immediate Track)
S025 2011-09-02 30-day Notice
S024 2009-03-20 30-day Notice
S023 2005-09-08 30-day Notice
S022
S021 2004-10-04 30-day Notice
S020 2003-06-11 30-day Notice
S019 2001-10-18 Real-time Process
S018 2001-05-23 30-day Notice
S017 2000-12-14 Normal 180 Day Track
S016 1998-12-21 Real-time Process
S015 1998-07-21 30-day Notice
S014 1995-03-16 Normal 180 Day Track
S013 1995-01-23 Normal 180 Day Track
S012 1994-06-07 Normal 180 Day Track
S011 1993-08-23 Normal 180 Day Track
S010 1991-10-07 Normal 180 Day Track
S009 1986-09-16 Special (immediate Track)
S008 1983-08-26
S007 1982-02-02
S006
S005 1981-08-20
S004 1980-07-21
S003 1980-07-08
S002 1980-06-16
S001 1980-01-28

NIH GUDID Devices

Device IDPMASupp
10801741000383 N17600 000
10801741010436 N17600 000
10801741010511 N17600 000
10801741000383 N17600 001
10801741010436 N17600 001
10801741010511 N17600 001
10801741010504 N17600 011
10801741010528 N17600 016
10801741010535 N17600 016
10801741010542 N17600 016
10801741010559 N17600 016
10801741223102 N17600 038
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