ORBERA Intragastric Balloon System
FDA premarket approval P140008/S018 · decided 2019-07-19
Approval details
- PMA number
- P140008
- Supplement
- S018
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ORBERA Intragastric Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-06-24
- Decision date
- 2019-07-19
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Additional supplier for the balloon shell and sheath components of your device and changing bioburden alert and action limits.
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