• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 
Trade NameGARREN{TM}-EDWARDS GASTRIC BUBBLE
Classification Nameimplant, intragastric for morbid obesity
Generic Nameintra-gastric anti-obesity implant
ApplicantAMERICAN EDWARDS LABORATORIES
PMA NumberP840025
Supplement NumberS005
Date Received03/27/1986
Decision Date05/12/1986
Product Code
LTI[ Registered Establishments with LTI ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
-
-