RESHAPE INTEGRATED DUAL BALLOON SYSTEM
FDA premarket approval P140012/S001 · decided 2016-01-14
Approval details
- PMA number
- P140012
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2015-08-26
- Decision date
- 2016-01-14
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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