ORBERA INTRAGASTRIC BALLOON SYSTEM
FDA premarket approval P140008/S001 · decided 2016-03-02
Approval details
- PMA number
- P140008
- Supplement
- S001
- Supplement type
- 135 Review Track For 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
- 2015-08-31
- Decision date
- 2016-03-02
- Days to decision
- 184 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval for the change in venders of manufacturing materials used to mold components of the ORBERA Intragastric Balloon System.
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