PMA
P000005: CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM
FDA PMA · SOLUTION, REMOVAL, CARRIES · Rls Global AB
Key facts
| PMA number | P000005 |
|---|---|
| Trade name | CARISOLV NON-INVASIVE DENTAL CARIES REMOVAL SYSTEM |
| Generic name | SOLUTION, REMOVAL, CARRIES |
| Applicant | Rls Global AB |
| Product code | LMW |
| Approval date | Jun 27, 2001 |
| Docket number | 01M-0337 |
| Notice date | Aug 13, 2001 |
At a glance
- 1–9 Supplements
- Oct 23, 2002 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- Yes Withdrawn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: