PMA supplement
P930012 S011: LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES
FDA PMA supplement · Real-Time Process · Progressive Angioplasty Systems, Inc.
Key facts
| Original PMA | P930012 |
|---|---|
| Supplement number | S011 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | LACROSSE/WRAP*PTCA CATHETERS;CHAMPION NC/WRAP NC PTCA CATHETER PRODUCT LINES |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Progressive Angioplasty Systems, Inc. |
| Product code | LOX |
| Received date | Aug 3, 1998 |
| Decision date | Sep 2, 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: