LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
FDA premarket approval P000008/S024 · decided 2011-07-29
Approval details
- PMA number
- P000008
- Supplement
- S024
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2011-07-14
- Decision date
- 2011-07-29
- Days to decision
- 15 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 FOR THE RAPIDPORT EZ PORT APPLIER, AN ACCESSORY TO THE LAP-BAND SYSTEM, TO CLARIFY THE PROPER METHOD OF HOLDING THE RAPIDPORT EZ PORT APPLIER AND HOW TO APPLY PRESSURE TO THE PORT APPLIER TO ENSURE THE CORRECT POSITIONING OF THE ACCESS PORT.
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