PMA
P030005: CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE
FDA PMA · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) · Guidant Corp.
Key facts
| PMA number | P030005 |
|---|---|
| Trade name | CONTAK RENEWAL MODELS H125 AND H120 WITH THE MODEL 2865 VERSION 1.8 APPLICATION SOFTWARE |
| Generic name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
| Applicant | Guidant Corp. |
| Owner/operator | Boston Scientific Corporation |
| Product code | NKE |
| Approval date | Jan 26, 2004 |
| Docket number | 04M-0064 |
| Notice date | Feb 24, 2004 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 100–999 Supplements
- Oct 3, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: