PMA
P910020: RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS
FDA PMA · Implantable pacemaker Pulse-generator · Boston Scientific
Key facts
| PMA number | P910020 |
|---|---|
| Trade name | RELAY(TM) MODELS 294-03 & 293-03 & DASH MODELS |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | DXY |
| Approval date | Jun 15, 1992 |
| Docket number | n2M-0263 |
| Notice date | Aug 7, 1992 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- Apr 23, 2012 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: