PMA P140012S005
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S005
- Product code
- LTI
- Decision date
- 2016-10-25
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Addition of an inspection step (spin test) during commercial manufacturing and quality control activities.
Current openFDA PMA Record#
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S005
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2016-10-25
- Decision code
- OK30
- Date received
- 2016-09-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an inspection step (spin test) during commercial manufacturing and quality control activities.