ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER,ETHICON ENDO-SURGERY GASTRIC BAND
FDA premarket approval P070009/S015 · decided 2015-04-20
Approval details
- PMA number
- P070009
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ETHICON ENDO-SURGERY CURVED ADJUSTABLE GASTRIC WITH SUTURELESS PORT AND APPLIER,ETHICON ENDO-SURGERY GASTRIC BAND
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2015-03-09
- Decision date
- 2015-04-20
- Days to decision
- 42 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- 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.
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