PMA
P950037: DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
FDA PMA · Implantable pacemaker Pulse-generator · Biotronik, Inc.
Key facts
| PMA number | P950037 |
|---|---|
| Trade name | DROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Biotronik, Inc. |
| Owner/operator | BIOTRONIK, INC. |
| Product code | DXY |
| Approval date | Oct 11, 1996 |
| Docket number | 97M-0251 |
| Notice date | Jul 2, 1997 |
| Establishment registration | 1028232 |
| FEI number | 1028232 |
At a glance
- 100–999 Supplements
- Oct 9, 2026 Latest supplement decision
- No Withdrawn
- No 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: