ORBERA Intragastric Balloon (IGB) System, Endoline Punc
FDA premarket approval P140008/S025 · decided 2023-12-14
Approval details
- PMA number
- P140008
- Supplement
- S025
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORBERA Intragastric Balloon (IGB) System, Endoline Punc
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2023-10-02
- Decision date
- 2023-12-14
- Days to decision
- 73 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- approval for the inclusion of the Prince Medical deflation needle to puncture and drain the ORBERA Intragastric Balloon (IGB) System during removal, thereby addressing a classification issue identified by FDA
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