PMA P140012S008
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S008
- Product code
- LTI
- Decision date
- 2017-02-21
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Change of lot release testing of finished catheter-balloon assemblies.
Current openFDA PMA Record#
- Device
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S008
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2017-02-21
- Decision code
- OK30
- Date received
- 2017-01-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change of lot release testing of finished catheter-balloon assemblies.