LAP-BAND

FDA premarket approval P000008/S017 · decided 2011-02-16

Approval details

PMA number

P000008

Supplement

S017

Supplement type

Panel Track

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

LAP-BAND

Generic name

IMPLANT, INTRAGASTRIC FOR MORBID OBESITY

Applicant

Medtimo, Inc.

Date received

2010-04-27

Decision date

2011-02-16

Days to decision

295 days

Decision code

APPR

Product code

LTI

Advisory committee

Gastroenterology, Urology

Expedited review

No

Location

Eden Prairie, MN

Statement

APPROVAL FOR LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM. THE LAP-BAND SYSTEM IS INDICATED FOR WEIGHT REDUCTION FOR PATIENTS WITH OBESITY, WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2 OR A BMI OF AT LEAST 30 KG/ M2 WITH ONE OR MORE OBESITY RELATED COMORBID CONDITIONS. IT IS INDICATED FOR USE IN ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT REDUCTION ALTERNATIVES, SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS. PATIENTS WHO ELECT TO HAVE THIS SURGERY MUST MAKE