PMA P140008S008
- Device
- ORBERA Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S008
- Product code
- LTI
- Decision date
- 2018-09-04
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for increases to the routine bioburden monitoring alert and action limits.
Current openFDA PMA Record#
- Device
- ORBERA Intragastric Balloon System
- Applicant
- Boston Scientific Corporation
- PMA number
- P140008
- Supplement
- S008
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2018-09-04
- Decision code
- APPR
- Date received
- 2017-11-06
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for increases to the routine bioburden monitoring alert and action limits.