PMA supplement
P940008 S003: RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS
FDA PMA supplement · Normal 180 Day Track · Boston Scientific
Key facts
| Original PMA | P940008 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | RES-Q(TM) ARRHYTHMIA CONTROL DEVICE SYSTEMS |
| Applicant | Boston Scientific |
| Received date | Feb 20, 1996 |
| Decision date | Aug 22, 1996 |
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: