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UPDATE: Potential Risks with Liquid-filled Intragastric …
- https://www.fda.gov/medical-devices/letters-health-care-providers/update-potential-risks-liquid-filled-intragastric-balloons-letter-health-care-providers
- In 2015, the FDA approved two liquid-filled intragastric balloon systems for use in the U.S., the Orbera and ReShape intragastric balloon systems. The Orbera Intragastric Balloon System is manufactured by Apollo Endosurgery and the ReShape Integrated Dual Balloon System, previously … See more
The FDA alerts health care providers about potential …
- https://www.fda.gov/medical-devices/letters-health-care-providers/fda-alerts-health-care-providers-about-potential-risks-liquid-filled-intragastric-balloons
- The ReShape Integrated Dual Balloon System is manufactured by ReShape Medical Inc., and uses two balloons. The Orbera Intragastric Balloon System manufactured by Apollo …
ReShape Lifesciences | Transformative …
- https://www.reshapelifesciences.com/
- ReShape Lifesciences Inc. is a worldwide premier weight-loss solutions company, offering an integrated portfolio of proven products and services that manage and treat …
ReShape ® is Now FDA Approved in the United States
- https://www.reshapelifesciences.com/2015/07/28/now-fda-approved-in-the-united-states/
- Proven to provide more than twice the weight loss of diet and exercise alone. Procedure integrated with 12 months of medically-supervised nutrition and exercise …
Summary of Safety and Effectiveness Data (SSED)
- https://www.accessdata.fda.gov/cdrh_docs/pdf14/P140012b.pdf
- ReShape Delivery Catheter The ReShape Delivery Catheter is supplied sterile, pre-loaded with a dual balloon, and packaged with a 0.035” stainless steel accessory …
ReShape Medical® Submits PMA …
- https://www.prnewswire.com/news-releases/reshape-medical-submits-pma-application-to-fda-for-non-surgical-weight-loss-device-265366721.html
- ReShape Medical is a medical device company focused on the development and commercialization of its dual intragastric balloon for weight loss. Driven by a …
ReShape ® FDA Approval Covered in Medical Device Daily
- https://www.reshapelifesciences.com/2015/08/03/reshape-fda-approval-covered-in-medical-device-daily/
- The FDA approved ReShape ‘s weight loss procedure in adults with a BMI of 30 to 40 kg/m 2 and a related health condition who have not been able to lose weight with …
MAUDE Adverse Event Report: RESHAPE MEDICAL, …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/detail.cfm?mdrfoi__id=6487551&pc=LTI
- There have been no design changes to the device since it was initially introduced to the market, and reshape has identified no steps in the manufacturing process that could …
MAUDE Adverse Event Report: RESHAPE MEDICAL, …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/detail.cfm?mdrfoi__id=6583328&pc=LTI
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM INTRAGASTRIC BALLOON MAUDE Adverse Event Report: RESHAPE MEDICAL, INC. RESHAPE INTEGRATED DUAL …
Class 2 Device Recall ReShape Integrated Dual Balloon …
- https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?id=148437
- ReShape Integrated Dual Balloon System, Gen 1, Catalog No. RSM110, Model No. 01-0013-001 The ReShape Integrated Dual Balloon System is indicated for …
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