PMA
P850023: HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT
FDA PMA · Agent, absorbable hemostatic, collagen based · Datascope Corp.
Key facts
| PMA number | P850023 |
|---|---|
| Trade name | HEMOPAD ABSORBABLE COLLAGEN HEMOSTAT |
| Generic name | Agent, absorbable hemostatic, collagen based |
| Applicant | Datascope Corp. |
| Owner/operator | Mindray DS USA, Inc. |
| Product code | LMF |
| Approval date | May 27, 1986 |
| Docket number | 86M-0248 |
| Notice date | Jul 7, 1986 |
| Establishment registration | 2221819 |
| FEI number | 2221819 |
At a glance
- 10–99 Supplements
- Dec 22, 1994 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- No Withdrawn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: