ENTER CORRECT TRADE NAME

FDA Premarket Approval N80535 S003

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

DeviceENTER CORRECT TRADE NAME
Generic NamePowder, Dusting, Surgical
ApplicantINGREDION INCORPORATED
Date Received1973-03-02
Decision Date1973-03-02
PMAN80535
SupplementS003
Advisory CommitteeGeneral Hospital
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address INGREDION INCORPORATED 10 Finderne Avenue suite C bridgewater, NJ 08807

Supplemental Filings

Supplement NumberDateSupplement Type
N80535Original Filing
S009 1999-03-19 Normal 180 Day Track
S008
S007
S006 1990-05-22 Normal 180 Day Track
S005 1989-08-21 Normal 180 Day Track
S004 1974-09-08 Normal 180 Day Track
S003 1973-03-02 Normal 180 Day Track
S002 1973-03-02 Normal 180 Day Track
S001 1973-03-02 Normal 180 Day Track

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