PMA supplement
P920047 S012: EPT-1000 CARDIAC ABLATION SYSTEM
FDA PMA supplement · Real-Time Process · Boston Scientific Corp
Key facts
| Original PMA | P920047 |
|---|---|
| Supplement number | S012 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | EPT-1000 CARDIAC ABLATION SYSTEM |
| Applicant | Boston Scientific Corp |
| Received date | Mar 23, 1999 |
| Decision date | Mar 30, 1999 |
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: