RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT
FDA premarket approval P140012/S004 · decided 2015-12-31
Approval details
- PMA number
- P140012
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESHAPE INTEGRATED DUAL BALLOON SYSTEM, RESHAPE BALLOON ASSEMBLY, RESHAPE REMOVAL CATHETER, RESHAPE VALVE SEALANT
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Boston Scientific Corporation
- Date received
- 2015-12-01
- Decision date
- 2015-12-31
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Marlboro, MA
- Statement
- ADDITION OF VESTA, INC., AS A SECOND SOURCE SUPPLIER OF THE BALLOON SHELL (P/N 03-0238).
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