PMA supplement
P910031 S022: MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW)
FDA PMA supplement · Normal 180 Day Track · Abbott Vascular Devices
Key facts
| Original PMA | P910031 |
|---|---|
| Supplement number | S022 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | MERLIN PTCA CATHETER (OTW) AND NC MERLIN PTCA CATHETER (OTW) |
| Generic name | Catheters, transluminal coronary angioplasty, percutaneous |
| Applicant | Abbott Vascular Devices |
| Product code | LOX |
| Received date | Nov 1, 2004 |
| Decision date | Feb 16, 2006 |
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: