PMA supplement
P900056 S191: Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System
FDA PMA supplement · Normal 180 Day Track No User Fee · Boston Scientific Corp
Key facts
| Original PMA | P900056 |
|---|---|
| Supplement number | S191 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Rotablator Rotational Atherectomy System and ROTAPRO Rotational Atherectomy System |
| Generic name | CATHETER, CORONARY, ATHERECTOMY |
| Applicant | Boston Scientific Corp |
| Product code | MCX |
| Received date | Oct 22, 2020 |
| Decision date | Nov 23, 2020 |
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: