PMA
P820076: DIPLOS MODEL 05 A & B
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · Biotronik, Inc.
Key facts
| PMA number | P820076 |
|---|---|
| Trade name | DIPLOS MODEL 05 A & B |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Biotronik, Inc. |
| Owner/operator | BIOTRONIK, INC. |
| Product code | LWP |
| Approval date | Feb 15, 1984 |
| Docket number | 84M-0089 |
| Notice date | Apr 6, 1984 |
| Establishment registration | 1028232 |
| FEI number | 1028232 |
At a glance
- 10–99 Supplements
- Feb 12, 2019 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: