LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
FDA premarket approval P000008 · decided 2001-06-05
Approval details
- PMA number
- P000008
- Trade name
- LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2000-02-09
- Decision date
- 2001-06-05
- Days to decision
- 482 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- Yes
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR THE LAP-BAND. ADJUSTABLE GASTRIC BANDING (LAGB.) SYSTEM. THE DEVICE IS INDICATED FOR USE IN WEIGHT REDUCTION FOR SEVERELY OBESE PATIENTS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 OR A BMI OF AT LEAST 35 WITH ONE OR MORE SEVERE COMORBID CONDITIONS, OR THOSE WHO ARE 100 LBS. OR MORE OVER THEIR ESTIMATED IDEAL WEIGHT ACCORDING TO THE 1983 METROPOLITAN LIFE INSURANCE TABLES (USE THE MIDPOINT FOR MEDIUM FRAME). IT IS INDICATED FOR USE ONLY IN SEVERELY OBESE ADULT PATIENTS WHO HAVE FAIL
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