PMA supplement
P900043 S008: PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM
FDA PMA supplement · Normal 180 Day Track · Cordis Corp.
Key facts
| Original PMA | P900043 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PALMAZ-SCHATZ(TM) BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM |
| Generic name | STENT, CORONARY |
| Applicant | Cordis Corp. |
| Product code | MAF |
| Received date | Dec 15, 1997 |
| Decision date | Jun 8, 1998 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: