PMA supplement
P890039 S016: POLY-SAFE(TM) A-TRACK(TM) PACING LEADS
FDA PMA supplement · Normal 180 Day Track · Cardiac Control Systems, Inc.
Key facts
| Original PMA | P890039 |
|---|---|
| Supplement number | S016 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | POLY-SAFE(TM) A-TRACK(TM) PACING LEADS |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Cardiac Control Systems, Inc. |
| Product code | DXY |
| Received date | Jul 19, 1996 |
| Decision date | Nov 9, 1998 |
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: