PMA
P000011: BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM
FDA PMA · STENT, CORONARY · Abbott Vascular, Inc.
Key facts
| PMA number | P000011 |
|---|---|
| Trade name | BIODIVYSIO AS PS (PHOSPHORYLCHOLINE)COATED STENT DELIVERY SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Abbott Vascular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MAF |
| Approval date | Sep 29, 2000 |
| Docket number | 01M-0055 |
| Notice date | Mar 9, 2001 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Dec 8, 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- Yes Withdrawn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: