ADEPT Adhesion Reduction Solution

FDA Premarket Approval P050011 S008

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 bag fill volume changes to the polyvinylchloride storage bag for the adept® adhesion reduction solution

DeviceADEPT Adhesion Reduction Solution
Generic NameBarrier, Absorbable, Adhesion
ApplicantBAXTER HEALTHCARE CORP.
Date Received2020-04-13
Decision Date2020-08-21
PMAP050011
SupplementS008
Product CodeMCN 
Advisory CommitteeObstetrics/Gynecology
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address BAXTER HEALTHCARE CORP. 1620 Waukegan Road mcgaw Park, IL 60085

Supplemental Filings

Supplement NumberDateSupplement Type
P050011Original Filing
S008 2020-04-13 Real-time Process
S007 2020-04-03 Real-time Process
S006 2017-05-17 Normal 180 Day Track No User Fee
S005 2013-08-02 Real-time Process
S004 2013-06-06 30-day Notice
S003 2012-04-24 Special (immediate Track)
S002 2010-11-03 135 Review Track For 30-day Notice
S001 2008-01-09 30-day Notice

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.