LAP-BAND System
FDA premarket approval P000008/S047 · decided 2019-11-13
Approval details
- PMA number
- P000008
- Supplement
- S047
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LAP-BAND System
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2019-07-24
- Decision date
- 2019-11-13
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- Approval for updates to three LAP-BAND® System Directions for Use and the Surgical Aid instructions with a change of the initial post-operative band fluid volume adjustment period to four weeks post-implantation.
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