PMA
P770005: HUNTER-SESSIONS VENA-CAVA OCCLUDER
FDA PMA · OCCLUDER, BALLOON, VENA-CAVA · Concept, Inc.
Key facts
| PMA number | P770005 |
|---|---|
| Trade name | HUNTER-SESSIONS VENA-CAVA OCCLUDER |
| Generic name | OCCLUDER, BALLOON, VENA-CAVA |
| Applicant | Concept, Inc. |
| Owner/operator | ADVANCED CONCEPT INNOVATIONS LLC |
| Product code | LWT |
| Approval date | Dec 19, 1977 |
| Notice date | May 20, 1978 |
| Establishment registration | 3006015326 |
| FEI number | 3006015326 |
At a glance
- None Supplements
- Dec 19, 1977 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- No Withdrawn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: