PMA
P990086: HEALTHTRONICS OSSATRON
FDA PMA · Generator, shock-wave, for pain relief · Sanuwave, Inc.
Key facts
| PMA number | P990086 |
|---|---|
| Trade name | HEALTHTRONICS OSSATRON |
| Generic name | Generator, shock-wave, for pain relief |
| Applicant | Sanuwave, Inc. |
| Owner/operator | SANUWAVE, INC. |
| Product code | NBN |
| Approval date | Oct 12, 2000 |
| Docket number | 01M-0271 |
| Notice date | Jun 18, 2001 |
| Establishment registration | 1062240 |
| FEI number | 3006261799 |
At a glance
- 1–9 Supplements
- Aug 6, 2004 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- Yes Withdrawn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: