RESHAPE INTEGRATED DUAL BALLOON SYSTEM
FDA premarket approval P140012/S006 · decided 2017-01-06
Approval details
- PMA number
- P140012
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2016-12-07
- Decision date
- 2017-01-06
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- Change Receipt inspection of packaging materials, reseal Valve Sealant packaging after inspection, and increase HEPA filtration and particulate alert and action levels.
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