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Reshape Integrated Dual Balloon System

by Boston Scientific

PMA P140012

Reshape Integrated Dual Balloon System is a Class III device made by Boston Scientific, approved under FDA PMA P140012 on 28 Jul 2015, withdrawn as of 22 Oct 2026.

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 28 Jul 2015

PMA

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA PMA, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP140012 Date28 Jul 2015Approval withdrawnStatusWithdrawn

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Withdrawn

Specification

PMA

Full name
Reshape Integrated Dual Balloon System, Reshape Balloon Assembly, Reshape Removal Catheter, Reshape Valve Sealant
Trade name
Reshape Integrated Dual Balloon System
Generic name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
FDA applicant
Boston Scientific Corporation
PMA number
FDA product code
LTI
Device class
Class III
Advisory committee
Gastroenterology, Urology
FDA decision
APWD Approval withdrawn

Devices cleared under P140012

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under P140012
UDI-DISize and differences
ReShape® Integrated Dual Balloon System RSM110
RESHAPE MEDICAL, INC.
RSM110 / RSM110B001RSM1101 —No longer on the market

Similar devices

Other devices filed under FDA product code LTI (Implant, Intragastric For Morbid Obesity).

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