Orbera Intragastric Balloon
FDA premarket approval P140008/S014 · decided 2018-11-28
Approval details
- PMA number
- P140008
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Orbera Intragastric Balloon
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2018-10-02
- Decision date
- 2018-11-28
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
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