GARREN GASTRIC BUBBLE

FDA Premarket Approval P840025 S011

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

DeviceGARREN GASTRIC BUBBLE
Generic NameImplant, Intragastric For Morbid Obesity
ApplicantAMERICAN EDWARDS LABORATORIES
Date Received1986-10-20
Decision Date1987-03-17
PMAP840025
SupplementS011
Product CodeLTI 
Advisory CommitteeGastroenterology/Urology
Supplement TypeSpecial (immediate Track)
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address AMERICAN EDWARDS LABORATORIES clayton Professional Bldg. suite 3a 118 North Street elkton, MD 21921-0000

Supplemental Filings

Supplement NumberDateSupplement Type
P840025Original Filing
S011 1986-10-20 Special (immediate Track)
S010
S009
S008 1986-08-08 Normal 180 Day Track
S007
S006 1986-05-14 Normal 180 Day Track
S005 1986-03-27 Normal 180 Day Track
S004 1985-12-16
S003 1985-11-29
S002 1985-11-04
S001 1985-10-28

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