ADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)

Barrier, Absorbable, Adhesion

FDA Premarket Approval P050011 S004

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

Replace the current peptidoglycan (pg) test method with a high sensitivity pg (hs-pg) test method.

DeviceADEPT ADHESION REDUCTION SOLUTION (4% ICODEXTRIN)
Classification NameBarrier, Absorbable, Adhesion
Generic NameBarrier, Absorbable, Adhesion
ApplicantBAXTER HEALTHCARE CORP.
Date Received2013-06-06
Decision Date2013-07-02
PMAP050011
SupplementS004
Product CodeMCN
Advisory CommitteeObstetrics/Gynecology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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

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