PMA
P880027: MICROSOFTRAC TM (PTCA) CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Boston Scientific
Key facts
| PMA number | P880027 |
|---|---|
| Trade name | MICROSOFTRAC TM (PTCA) CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | LOX |
| Approval date | Apr 14, 1989 |
| Docket number | 89M-0143 |
| Notice date | May 19, 1989 |
| Establishment registration | 2134265 |
| FEI number | 3002095335 |
At a glance
- 10–99 Supplements
- Oct 31, 2005 Latest supplement decision
- Yes Withdrawn
- No 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: