PMA
P070009: REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X
FDA PMA · IMPLANT, INTRAGASTRIC FOR MORBID OBESITY · Obtech Medical GmbH
Key facts
| PMA number | P070009 |
|---|---|
| Trade name | REALIZE ADJUSTABLE GASTRIC BAND MODEL 2200-X |
| Generic name | IMPLANT, INTRAGASTRIC FOR MORBID OBESITY |
| Applicant | Obtech Medical GmbH |
| Product code | LTI |
| Approval date | Sep 28, 2007 |
| Docket number | 07M-0380 |
| Notice date | Nov 9, 2007 |
| FEI number | 3005992282 |
At a glance
- 10–99 Supplements
- Oct 11, 2016 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: