|
Device | BIOENTERICS LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM |
Generic Name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
Applicant | ReShape Lifesciences, Inc. 1001 Calle Amanecer San Clemente, CA 92672 |
PMA Number | P000008 |
Supplement Number | S004 |
Date Received | 03/14/2002 |
Decision Date | 09/10/2002 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A DESIGN MODIFICATION TO THE LAP-BAND SYSTEM'S ACCESS PORT WITH TAPERED CONNECTOR. |