PMA supplement
P790017 S045: USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL
FDA PMA supplement · Normal 180 Day Track · Medtronic, Ireland
Key facts
| Original PMA | P790017 |
|---|---|
| Supplement number | S045 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | USCI(R) SILK(TM)/AGIL(TM) BALL.DIL.CATH. W/PRO/PEL |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Medtronic, Ireland |
| Product code | LOX |
| Received date | Apr 3, 1991 |
| Decision date | Jan 7, 1994 |
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: