ORBERA Intragastric Balloon System
FDA premarket approval P140008/S017 · decided 2019-06-03
Approval details
- PMA number
- P140008
- Supplement
- S017
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORBERA Intragastric Balloon System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2019-03-04
- Decision date
- 2019-06-03
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Approval for revised labeling to include current post-market surveillance information, clarifications intended to enhance safety, and additional labeling pieces intended to enhance safety.
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