PMA P000008S045
- Device
- LAP-BAND Adjustable Gastric Banding System
- Applicant
- Medtimo, Inc.
- PMA number
- P000008
- Supplement
- S045
- Product code
- LTI
- Decision date
- 2019-05-02
- Classification
- Implant, Intragastric For Morbid Obesity
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Approval order statement
- Approval for the pneumatic assist to automatically load and unload catheter tubing on the punch mandrel.
Current openFDA PMA Record#
- Device
- LAP-BAND Adjustable Gastric Banding System
- Applicant
- Medtimo, Inc.
- PMA number
- P000008
- Supplement
- S045
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2019-05-02
- Decision code
- APPR
- Date received
- 2018-12-18
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the pneumatic assist to automatically load and unload catheter tubing on the punch mandrel.