ANTI-REFLUX PROSTHESIS

FDA Premarket Approval P790006 S001

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

DeviceANTI-REFLUX PROSTHESIS
Generic NameImplant, Anti-gastroesophageal Reflux
ApplicantAllergan, Inc.
Date Received1980-01-10
Decision Date1980-09-10
PMAP790006
SupplementS001
Product CodeLEI 
Advisory CommitteeGastroenterology/Urology
Expedited ReviewNo
Combination Product No
Applicant Address Allergan, Inc. 5540 Ekwill Street santa Barbara, CA 93111

Supplemental Filings

Supplement NumberDateSupplement Type
P790006Original Filing
S005 1990-06-21 Normal 180 Day Track
S004 1984-05-03
S003 1983-06-13
S002 1981-04-02
S001 1980-01-10

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