PMA
P070008: STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD
FDA PMA · Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) · Biotronik, Inc.
Key facts
| PMA number | P070008 |
|---|---|
| Trade name | STRATOS LV CRT-P AND STRATOS LV-T CRT-P, COROX OTW BP LEAD AND COROX OTW-S BP LEAD |
| Generic name | Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) |
| Applicant | Biotronik, Inc. |
| Owner/operator | BIOTRONIK, INC. |
| Product code | NKE |
| Approval date | May 12, 2008 |
| Docket number | 08M-0335 |
| Notice date | Jun 5, 2008 |
| Establishment registration | 1028232 |
| FEI number | 1028232 |
At a glance
- 100–999 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 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: