PMA
P990008: COOK MBC PTCA BALLOON DILATATION CATHETER
FDA PMA · Catheters, transluminal coronary angioplasty, percutaneous · Cook, Inc.
Key facts
| PMA number | P990008 |
|---|---|
| Trade name | COOK MBC PTCA BALLOON DILATATION CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Cook, Inc. |
| Owner/operator | COOK, INC. |
| Product code | LOX |
| Approval date | Sep 27, 1999 |
| Docket number | 99M-4276 |
| Notice date | Oct 18, 1999 |
| Establishment registration | 1820334 |
| FEI number | 1820334 |
At a glance
- None Supplements
- Sep 27, 1999 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- Yes Withdrawn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: