PMA supplement
P130005 S037: DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION ™ Coronary Orbital Atherectomy System (OAS)
FDA PMA supplement · Real-Time Process · Cardiovascular Systems, Inc.
Key facts
| Original PMA | P130005 |
|---|---|
| Supplement number | S037 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | DIAMONDBACK 360® and DIAMONDBACK 360 PRECISION ™ Coronary Orbital Atherectomy System (OAS) |
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Applicant | Cardiovascular Systems, Inc. |
| Product code | MCX |
| Received date | Jun 13, 2023 |
| Decision date | Jul 28, 2023 |
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: