- Device
- ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER,ETHICON ENDO-SURGERY GASTRIC BAND
- Applicant
- Obtech Medical GmbH
- PMA number
- P070009
- Supplement
- S015
- Product code
- LTI
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Decision date
- 2015-04-20
- Decision code
- OK30
- Date received
- 2015-03-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A PACKAGE INSPECTION STEP FOR THE ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER, AND THE ETHICON ENDO-SURGERY GASTRIC BAND SUTURELESS PORT AND APPLIER.