REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND APPLIER
FDA premarket approval P070009/S010 · decided 2010-07-26
Approval details
- PMA number
- P070009
- Supplement
- S010
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- REALIZE ADJUSTABLE GASTRIC BAND-C WITH INJECTION PORT AND APPLIER
- Generic name
- IMPLANT, INTRAGASTRIC FOR MORBID OBESITY
- Applicant
- Obtech Medical GmbH
- Date received
- 2010-06-29
- Decision date
- 2010-07-26
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LTI
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Zug
- Statement
- ADDITION OF AN ALTERNATE SUB-ASSEMBLY SUPPLIER.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.