PMA supplement
P810046 S187: PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER
FDA PMA supplement · Normal 180 Day Track · Advanced Cardiovascular Systems, Inc.
Key facts
| Original PMA | P810046 |
|---|---|
| Supplement number | S187 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | PYROGEN TESTING OF ACS/CORNARY DILATATION CATHETERS E-BEAM- RADIATION STERILIZER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Advanced Cardiovascular Systems, Inc. |
| Product code | LOX |
| Received date | Jan 26, 1998 |
| Decision date | Dec 28, 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: