|
Device | 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 | S018 |
Date Received | 05/21/2010 |
Decision Date | 06/18/2010 |
Product Code |
LTI |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Special (Immediate Track) |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO MODIFY THE INSTRUCTIONS FOR USE TO ADD ¿DATA FROM A POST-APPROVAL STUDY SHOWED AN ESTIMATED EXPLANT RATE OF 6.5% PER YEAR OVER THE FIRST FIVE YEARS FOLLOWING IMPLANTATION¿ TO THE ADVERSE EVENTS SECTION. |