LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008/S020 · decided 2010-10-08
Approval details
- PMA number
- P000008
- Supplement
- S020
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2010-09-16
- Decision date
- 2010-10-08
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL TO MODIFY THE DIRECTIONS FOR USE TO ADD CAUTIONARY STATEMENTS REGARDING HOW THE NEEDLE IS TO BE INSERTED INTO THE ACCESS PORT SEPTUM TO PREVENT DAMAGE TO THE ACCESS PORT.
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