PMA P140012S003
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S003
- Product code
- LTI
- Decision date
- 2016-01-22
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- APPROVAL FOR A DIMENSIONAL CHANGE TO THE TORQUE TRANSMISSION WIRE COMPONENT OF THE RESHAPE REMOVAL CATHETER ASSEMBLY.
Current openFDA PMA Record#
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S003
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2016-01-22
- Decision code
- APPR
- Date received
- 2015-11-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A DIMENSIONAL CHANGE TO THE TORQUE TRANSMISSION WIRE COMPONENT OF THE RESHAPE REMOVAL CATHETER ASSEMBLY.