PMA supplement
P850021 S021: OEACH(TM).14,& READY(TM).14,PTCA CATHETER
FDA PMA supplement · Normal 180 Day Track · Abbott Vascular, Inc.
Key facts
| Original PMA | P850021 |
|---|---|
| Supplement number | S021 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | OEACH(TM).14,& READY(TM).14,PTCA CATHETER |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Abbott Vascular, Inc. |
| Product code | LOX |
| Received date | Nov 16, 1992 |
| Decision date | Feb 4, 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: