Premarket Approval (PMA)

Note: 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.

• Device: GARREN GASTRIC BUBBLE
• Generic Name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
• Applicant: American Edwards Laboratories; Clayton Professional Bldg.; Suite 3a 118 N. St.; Elkton, MD 21921
• PMA Number: P840025
• Supplement Number: S001
• Date Received: 10/28/1985
• Decision Date: 12/18/1985
• Product Code: LTI
• Advisory Committee: Gastroenterology/Urology
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No