LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008/S018 · decided 2010-06-18
Approval details
- PMA number
- P000008
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Trade name
- LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2010-05-21
- Decision date
- 2010-06-18
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL TO MODIFY THE INSTRUCTIONS FOR USE TO ADD ¿DATA FROM A POST-APPROVAL STUDY SHOWED AN ESTIMATED EXPLANT RATE OF 6.5% PER YEAR OVER THE FIRST FIVE YEARS FOLLOWING IMPLANTATION¿ TO THE ADVERSE EVENTS SECTION.
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