PMA supplement
P030005 S005: GUIDANT CONTAK RENEWAL TR MODELS H125 AND H120
FDA PMA supplement · Normal 180 Day Track · Guidant Corp.
Key facts
| Original PMA | P030005 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | GUIDANT CONTAK RENEWAL TR MODELS H125 AND H120 |
| Generic name | Permanent pacemaker Electrode |
| Applicant | Guidant Corp. |
| Product code | DTB |
| Received date | Nov 22, 2004 |
| Decision date | Mar 8, 2005 |
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: