PMA
P860027: MAESTRO SERIES 500 P.G. MODELS 501, 505, 509
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · Cardiac Control Systems, Inc.
Key facts
| PMA number | P860027 |
|---|---|
| Trade name | MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Cardiac Control Systems, Inc. |
| Product code | LWP |
| Approval date | Feb 27, 1987 |
| Docket number | 87M-0085 |
| Notice date | Apr 16, 1987 |
At a glance
- 10–99 Supplements
- Jul 29, 1997 Latest supplement decision
- No Withdrawn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: