LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008/S032 · decided 2014-11-05
Approval details
- PMA number
- P000008
- Supplement
- S032
- 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
- 2014-10-06
- Decision date
- 2014-11-05
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR LABELING MODIFICATIONS TO 1) ADD IDENTIFIERS TO A PICTURE OF ACALIBRATION TUBE; AND (2) ADD A NOTE THAT THE USER SHOULD NOT OVERINFLATE THE BALLOON.
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