PMA supplement
P980003 S020: MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050
FDA PMA supplement · Special (Immediate Track) · Boston Scientific Corp
Key facts
| Original PMA | P980003 |
|---|---|
| Supplement number | S020 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MODEL 8005 PUMP SYSTEM (CIRCUCOOL PUMP), MODEL M00480050 |
| Generic name | Cardiac ablation percutaneous catheter |
| Applicant | Boston Scientific Corp |
| Product code | LPB |
| Received date | Sep 27, 2007 |
| Decision date | Oct 29, 2007 |
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: