PMA
P990015: INTERGEL ADHESION PREVENTION SOLUTION
FDA PMA · Barrier, absorbable, adhesion · Lifecore Biomedical, Inc.
Key facts
| PMA number | P990015 |
|---|---|
| Trade name | INTERGEL ADHESION PREVENTION SOLUTION |
| Generic name | Barrier, absorbable, adhesion |
| Applicant | Lifecore Biomedical, Inc. |
| Owner/operator | LIFECORE BIOMEDICAL, LLC |
| Product code | MCN |
| Approval date | Nov 16, 2001 |
| Docket number | 01M-0523 |
| Notice date | Nov 21, 2001 |
| Establishment registration | 2184002 |
| FEI number | 1000115753 |
At a glance
- 1–9 Supplements
- Mar 18, 2003 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- Yes Withdrawn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: