PMA
P800040: CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A,
FDA PMA · Stimulator, spinal-cord, totally implanted for pain relief · Cordis Corp.
Key facts
| PMA number | P800040 |
|---|---|
| Trade name | CORDIS PROGRAMMABLE NEURAL STIMULATOR MODELS 900A, |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Cordis Corp. |
| Owner/operator | Cordis US Corp. |
| Product code | LGW |
| Approval date | Apr 14, 1981 |
| Docket number | 81M-0136 |
| Notice date | Jun 5, 1981 |
| Establishment registration | 1016427 |
| FEI number | 1016427 |
At a glance
- 10–99 Supplements
- Mar 22, 1988 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- Yes Withdrawn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: