FDA.reportPublic FDA data

PMA P000008S047

Device
LAP-BAND System
Applicant
Medtimo, Inc.
PMA number
P000008
Supplement
S047
Product code
LTI
Decision date
2019-11-13
Classification
Implant, Intragastric For Morbid Obesity
Generic name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Approval order statement
Approval for updates to three LAP-BAND® System Directions for Use and the Surgical Aid instructions with a change of the initial post-operative band fluid volume adjustment period to four weeks post-implantation.

Current openFDA PMA Record#

Device
LAP-BAND System
Applicant
Medtimo, Inc.
PMA number
P000008
Supplement
S047
Product code
LTI
Generic name
IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
Decision date
2019-11-13
Decision code
APPR
Date received
2019-07-24
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for updates to three LAP-BAND® System Directions for Use and the Surgical Aid instructions with a change of the initial post-operative band fluid volume adjustment period to four weeks post-implantation.