PMA supplement
P130005 S010: DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE
FDA PMA supplement · 30-Day Notice · Cardiovascular Systems, Inc.
Key facts
| Original PMA | P130005 |
|---|---|
| Supplement number | S010 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | DIAMONDBACK 360 CORONARY ORBITAL ATHERECTOMY DEVICE (OAD), ORBITAL ATHERECTOMY SYSTEM PUMP (OAS PUMP), VIPERWIRE ADVANCE |
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Applicant | Cardiovascular Systems, Inc. |
| Product code | MCX |
| Received date | Dec 23, 2015 |
| Decision date | Jan 21, 2016 |
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: