VITAGEL RT3 SURGICAL HEMOSTAT

Agent, Absorbable Hemostatic, Collagen Based

FDA Premarket Approval P050044 S025

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 device name change for the vitagel rt surgical hemostat. The device, as modified, will be marketed under the trade name vitagel rt3 surgical hemostat with no change in the indications for use.

• Device: VITAGEL RT3 SURGICAL HEMOSTAT
• Classification Name: Agent, Absorbable Hemostatic, Collagen Based
• Generic Name: Agent, Absorbable Hemostatic, Collagen Based
• Applicant: STRYKER CORP.
• Date Received: 2013-10-22
• Decision Date: 2013-11-15
• PMA: P050044
• Supplement: S025
• Product Code: LMF
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: STRYKER CORP. 2825 Airview Boulevard portage, MI 49002

Supplemental Filings

Supplement Number	Date	Supplement Type
P050044		Original 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 ID	PMA	Supp
30808232000819	P050044	000
30808232000802	P050044	000
30808232001243	P050044	019
00808232001280	P050044	021
00808232001273	P050044	021
30808232001397	P050044	028
30808232001380	P050044	028