PMA
P990016: MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0
FDA PMA · Bone sonometer · CooperSurgical, Inc.
Key facts
| PMA number | P990016 |
|---|---|
| Trade name | MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 |
| Generic name | Bone sonometer |
| Applicant | CooperSurgical, Inc. |
| Owner/operator | COOPERSURGICAL, INC. |
| Product code | MUA |
| Approval date | Jan 7, 2000 |
| Docket number | 00M-0580 |
| Notice date | Feb 15, 2000 |
| Establishment registration | 1216677 |
| FEI number | 1216677 |
At a glance
- 1–9 Supplements
- Mar 28, 2002 Latest supplement decision
- No Withdrawn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: