PMA P070009S003

Device: REALIZE ADJUSTABLE GASTRIC BAND
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S003
Product code: LTI
Decision date: 2008-10-15
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement: APPROVAL FOR A LINE EXTENSION TO THE REALIZE ADJUSTABLE GASTRIC BANDTHE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REALIZE ADJUSTABLE GASTRICBAND CURVED (MODEL BD3XV) AND IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTSAND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OFAT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS. THE BAND IS INDICATED FOR USE ONLY INMORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES,SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.

Current openFDA PMA Record#

Device: REALIZE ADJUSTABLE GASTRIC BAND
Applicant: Obtech Medical GmbH
PMA number: P070009
Supplement: S003
Product code: LTI
Generic name: IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date: 2008-10-15
Decision code: APPR
Date received: 2008-04-18
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A LINE EXTENSION TO THE REALIZE ADJUSTABLE GASTRIC BANDTHE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REALIZE ADJUSTABLE GASTRICBAND CURVED (MODEL BD3XV) AND IS INDICATED FOR WEIGHT REDUCTION FOR MORBIDLY OBESE PATIENTSAND IS INDICATED FOR INDIVIDUALS WITH A BODY MASS INDEX (BMI) OF AT LEAST 40 KG/M2, OR A BMI OFAT LEAST 35 KG/M2 WITH ONE OR MORE COMORBID CONDITIONS. THE BAND IS INDICATED FOR USE ONLY INMORBIDLY OBESE ADULT PATIENTS WHO HAVE FAILED MORE CONSERVATIVE WEIGHT-REDUCTION ALTERNATIVES,SUCH AS SUPERVISED DIET, EXERCISE AND BEHAVIOR MODIFICATION PROGRAMS.