ORBERA Intragastric Balloon System
FDA premarket approval P140008/S005 · decided 2017-05-01
Approval details
- PMA number
- P140008
- Supplement
- S005
- 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
- 2017-04-12
- Decision date
- 2017-05-01
- Days to decision
- 19 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Addition of a new supplier of a device component.
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