PMA
P080029: QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM)
FDA PMA · Device, hemostasis, vascular · Cardiva Medical, Inc.
Key facts
| PMA number | P080029 |
|---|---|
| Trade name | QUICK-CLOSE VASCULAR SUTURING SYSTEM (QUICK-CLOSE SYSTEM) |
| Generic name | Device, hemostasis, vascular |
| Applicant | Cardiva Medical, Inc. |
| Owner/operator | CARDIVA MEDICAL, INC. |
| Product code | MGB |
| Approval date | Apr 8, 2010 |
| Docket number | 10M-0220 |
| Notice date | Apr 23, 2010 |
| Establishment registration | 3015145497 |
| FEI number | 3015145497 |
At a glance
- 1–9 Supplements
- Dec 18, 2014 Latest supplement decision
- No Withdrawn
- Yes 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: