PMA supplement
P030005 S113: INGENIO 2 CRT-P DEVICES AND INGENIO CRT-P DEVICES
FDA PMA supplement · Normal 180 Day Track · Guidant Corp.
Key facts
| Original PMA | P030005 |
|---|---|
| Supplement number | S113 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | INGENIO 2 CRT-P DEVICES AND INGENIO CRT-P DEVICES |
| Generic name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
| Applicant | Guidant Corp. |
| Product code | NKE |
| Received date | Jul 25, 2014 |
| Decision date | Oct 21, 2014 |
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: