• 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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceObalon Ballon System with Navigation and Touch
Generic Nameimplant, intragastric for morbid obesity
Applicant
ReShape Lifesciences, Inc.
1001 calle amanecer
san clemente, CA 92673
PMA NumberP160001
Supplement NumberS044
Date Received11/13/2019
Decision Date02/11/2020
Product Code LTI 
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the software of the Obalon Navigation Console.
-
-