PMA P140012S007
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S007
- Product code
- LTI
- Decision date
- 2017-01-06
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Addition of a 100% visual inspection step of the flapper valve.
Current openFDA PMA Record#
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S007
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2017-01-06
- Decision code
- OK30
- Date received
- 2016-12-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a 100% visual inspection step of the flapper valve.