PMA
P070005: REPEL-CV BIORESORBABLE ADHESION BARRIER
FDA PMA · Barrier, adhesion, cardiovascular · Pathfinder Cell Therapy, Inc.
Key facts
| PMA number | P070005 |
|---|---|
| Trade name | REPEL-CV BIORESORBABLE ADHESION BARRIER |
| Generic name | Barrier, adhesion, cardiovascular |
| Applicant | Pathfinder Cell Therapy, Inc. |
| Product code | OBD |
| Approval date | Mar 6, 2009 |
| Docket number | 09M-0135 |
| Notice date | Mar 11, 2009 |
| FEI number | 1000208867 |
At a glance
- 1–9 Supplements
- Apr 30, 2014 Latest supplement decision
- Yes Withdrawn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: