REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
FDA premarket approval P070009/S013 · decided 2011-03-31
Approval details
- PMA number
- P070009
- Supplement
- S013
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- REALIZE ADJUSTABLE GASTRIC BANDS WITH INJECTION PORT & APPLIER
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2011-02-08
- Decision date
- 2011-03-31
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- APPROVAL FOR A DEVICE CHANGE TO MODIFY THE SILICONE MATERIAL USED FOR THE INJECTION PORT SEPTUM AND INJECTION PORT CONNECTOR SLEEVE COMPONENTS, ALONG WITH A MINOR ASSOCIATED LABELING MODIFICATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.