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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSpatz3 Adjustable Balloon System
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantSpatz Fgia, Inc.
1801 S Perimeter Rd.
Suite 130
Ft. Lauderdale, FL 33309
PMA NumberP190012
Supplement NumberS004
Date Received01/31/2024
Decision Date02/29/2024
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
for preparation of dye solution for package integrity and manufacturing clean room environment
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