VITAGEL RT3 SURGICAL HEMOSTAT

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval P050044 S032

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

Modifications to the on-going real time stability study which is used for establishing shelf life for vitagel rt3 surgical hemostat.

DeviceVITAGEL RT3 SURGICAL HEMOSTAT
Classification NameAgent, Absorbable Hemostatic, Collagen Based
Generic NameAgent, Absorbable Hemostatic, Collagen Based
ApplicantSTRYKER CORP.
Date Received2015-06-16
Decision Date2015-07-16
PMAP050044
SupplementS032
Product CodeLMF
Advisory CommitteeGeneral & Plastic Surgery
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address STRYKER CORP. 2825 Airview Boulevard portage, MI 49002

Supplemental Filings

Supplement NumberDateSupplement Type
P050044Original Filing
S033 2017-01-31 30-day Notice
S032 2015-06-16 30-day Notice
S031 2015-03-12 30-day Notice
S030 2015-03-12 30-day Notice
S029 2014-07-23 135 Review Track For 30-day Notice
S028 2014-03-07 Real-time Process
S027 2013-11-29 135 Review Track For 30-day Notice
S026 2013-11-14 Real-time Process
S025 2013-10-22 Normal 180 Day Track No User Fee
S024 2012-09-04 30-day Notice
S023 2012-08-29 Special (immediate Track)
S022
S021 2011-10-27 Normal 180 Day Track
S020
S019 2011-08-01 Normal 180 Day Track
S018 2011-06-29 30-day Notice
S017 2011-01-28 30-day Notice
S016 2011-01-18 Special (immediate Track)
S015 2010-11-02 30-day Notice
S014 2010-06-09 30-day Notice
S013 2010-03-05 30-day Notice
S012 2010-01-04 Normal 180 Day Track No User Fee
S011 2009-09-23 30-day Notice
S010 2009-09-01 30-day Notice
S009 2009-06-23 30-day Notice
S008 2008-12-29 30-day Notice
S007 2008-11-04 30-day Notice
S006 2008-10-15 30-day Notice
S005 2008-05-19 Special (immediate Track)
S004 2008-03-26 30-day Notice
S003 2007-11-06 Normal 180 Day Track No User Fee
S002 2007-11-06 Normal 180 Day Track No User Fee
S001 2006-08-08 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
30808232000819 P050044 000
30808232000802 P050044 000
30808232001243 P050044 019
00808232001280 P050044 021
00808232001273 P050044 021
30808232001397 P050044 028
30808232001380 P050044 028
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