BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
FDA premarket approval P000008/S002 · decided 2002-08-01
Approval details
- PMA number
- P000008
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING (LAGB) SYSTEM
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Medtimo, Inc.
- Date received
- 2002-01-24
- Decision date
- 2002-08-01
- Days to decision
- 189 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Eden Prairie, MN
- Statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE LAP-BAND ADUSTABLE GASTRIC BANDING (LAGB) SYSTEM: 1) INTRODUCTION OF A REDESIGNED ACCESS PORT (ACCESS PORT II); 2) REPLACE THE CALIBRATION TUBE (CALIBRATION TUBE I) CURRENTLY PROVIDED IN THE LAGB) SYSTEM WITH A REDESIGNED CALIBRATION TUBE (CALIBRATION TUBE II); AND 3) INTRODUCTION OF 2" ACCESS PORT NEEDLES TO BE SOLD AS AN ACCESSORY ITEM. IN ADDITION TO BEING SOLD AS COMPONENTS OF THE LAGB SYSTEM, BOTH THE ACCESS PORT II AND THE CALIBRATION TUBE II
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