ARTERX SURGICAL SEALANT,

Sealant, Polymerizing

FDA Premarket Approval P100030 S002

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 to extend the shelf life for arterx surgical sealant from 12 months to 24 months when stored at2-8c and to extend the shelf life for the arterx delivery tips from 12 months to 42 months.

• Device: ARTERX SURGICAL SEALANT,
• Classification Name: Sealant, Polymerizing
• Generic Name: Sealant, Polymerizing
• Applicant: Baxter Healthcare Corporation
• Date Received: 2013-09-03
• Decision Date: 2013-11-05
• PMA: P100030
• Supplement: S002
• Product Code: NBE
• Advisory Committee: Cardiovascular
• Supplement Type: Real-time Process
• Supplement Reason: Labeling Change - Indications/instructions/shelf Life/tradename
• Expedited Review: No
• Combination Product: No
• Applicant Address: Baxter Healthcare Corporation one Baxter Parkway deerfield, IL 60015

Supplemental Filings

Supplement Number	Date	Supplement Type
P100030		Original Filing
S016	2021-11-10	30-day Notice
S015	2021-06-28	30-day Notice
S014	2020-09-14	Real-time Process
S013
S012
S011	2017-07-31	30-day Notice
S010	2017-07-26	30-day Notice
S009	2017-07-07	135 Review Track For 30-day Notice
S008	2017-07-03	Panel Track
S007	2017-05-30	Real-time Process
S006
S005	2016-07-26	Normal 180 Day Track No User Fee
S004	2014-05-22	Normal 180 Day Track No User Fee
S003
S002	2013-09-03	Real-time Process
S001	2013-09-03	Real-time Process

NIH GUDID Devices

Device ID	PMA	Supp
25413765583609	P100030	013
25413765583593	P100030	013
25413765583586	P100030	013
25413765583524	P100030	014