PMA
P000026: STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20
FDA PMA · Intraocular pressure lowering implant · Starr Surgical Co.
Key facts
| PMA number | P000026 |
|---|---|
| Trade name | STAAR SURGICAL COMPANY AQUAFLOW(TM) COLLAGEN GLAUCOMA DRAINAGE DEVICE, MODEL CGDD-20 |
| Generic name | Intraocular pressure lowering implant |
| Applicant | Starr Surgical Co. |
| Owner/operator | STAAR SURGICAL Company |
| Product code | OGO |
| Approval date | Jul 12, 2001 |
| Docket number | 01M-0307 |
| Notice date | Jul 23, 2001 |
| Establishment registration | 2023826 |
| FEI number | 2023826 |
At a glance
- 1–9 Supplements
- Jun 17, 2010 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- Yes Withdrawn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: