PMA
P020021: WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER
FDA PMA · System, laser, fiber optic, photodynamic therapy · Cook Endoscopy
Key facts
| PMA number | P020021 |
|---|---|
| Trade name | WIZARD X-CELL PHOTODYNAMIC THERAPY BALLOON WITH FIBER OPTIC DIFFUSER |
| Generic name | System, laser, fiber optic, photodynamic therapy |
| Applicant | Cook Endoscopy |
| Owner/operator | COOK ENDOSCOPY |
| Product code | MVG |
| Approval date | Aug 1, 2003 |
| Docket number | 04M-0495 |
| Notice date | Nov 12, 2004 |
| Establishment registration | 1037905 |
| FEI number | 1037905 |
At a glance
- None Supplements
- Aug 1, 2003 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- Yes Withdrawn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: