AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval P800002 S009

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

DeviceAVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT(MCH)
Classification NameAgent, Absorbable Hemostatic, Collagen Based
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantC.R. Bard, Inc.
Date Received1992-01-21
Decision Date1993-04-09
PMAP800002
SupplementS009
Product CodeLMF
Advisory CommitteeGeneral & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement ReasonLocation 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
10801741010474 P800002 001
10801741010467 P800002 001
10801741010450 P800002 001
10801741010498 P800002 008
10801741010481 P800002 008

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.