Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
 
DeviceTransPyloric Shuttle/TransPyloric Shuttle Delivery Device
Generic NameIMPLANT, INTRAGASTRIC FOR MORBID OBESITY
ApplicantBaronova, Inc.
1509 Industrial Rd.
San Carlos, CA 94070
PMA NumberP180024
Date Received07/09/2018
Decision Date04/16/2019
Product Code LTI 
Docket Number 19M-1848
Notice Date 04/18/2019
Advisory Committee Gastroenterology/Urology
Clinical TrialsNCT02518685
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the TransPyloric Shuttle/TransPyloric Shuttle Delivery Device. The TransPyloric Shuttle/TransPyloric Shuttle Delivery Device is indicated for weight reduction in adult patients with obesity with a Body Mass Index (BMI) of 35.0-40.0 kg/m2 or a BMI of 30.0 to 34.9 kg/m2 with one or more obesity-related comorbid conditions and is intended to be used in conjunction with a diet and behavior modification program.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
-
-