PMA
P130005: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM
FDA PMA · CATHETER, CORONARY, ATHERECTOMY · Cardiovascular Systems, Inc.
Key facts
| PMA number | P130005 |
|---|---|
| Trade name | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY SYSTEM |
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Applicant | Cardiovascular Systems, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MCX |
| Approval date | Oct 21, 2013 |
| Docket number | 13M-1363 |
| Notice date | Oct 30, 2013 |
| Establishment registration | 3004742232 |
| FEI number | 3004742232 |
At a glance
- 10–99 Supplements
- Mar 10, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: