PMA P140012S011
- Device
- ReShape Integrated Dual Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S011
- Product code
- LTI
- Decision date
- 2017-10-26
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Reduce the frequency of sterility dose auditing for the ReShape Integrated Dual Balloon System and ReShape Removal Catheter.
Current openFDA PMA Record#
- Device
- ReShape Integrated Dual Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140012
- Supplement
- S011
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2017-10-26
- Decision code
- OK30
- Date received
- 2017-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduce the frequency of sterility dose auditing for the ReShape Integrated Dual Balloon System and ReShape Removal Catheter.