PMA supplement
P860008 S023: TAPSCOPE 550 - 200-0010, 200-0025, 250-0010, 250-0025
FDA PMA supplement · 30-Day Notice · Cardio Command
Key facts
| Original PMA | P860008 |
|---|---|
| Supplement number | S023 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TAPSCOPE 550 - 200-0010, 200-0025, 250-0010, 250-0025 |
| Generic name | SYSTEM, ESOPHAGEAL PACING |
| Applicant | Cardio Command |
| Product code | LPA |
| Received date | May 16, 2017 |
| Decision date | Jun 19, 2017 |
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: