This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval to perform a quantitative ultrasound measurement of the calcaneus (heel bone), the results of which can be used in conjunction with other clinical risk factors as an aid for the diagnosis of osteoporosis and other medical conditions leading to reduced bone density and, ultimately, for the determination of fracture risk.
| Device | MCCUE CUBACLINICAL ULTRASONIC BONE SONOMETRY SYSTEM WITH CUBAPLUS+ V4.1.0 |
| Generic Name | Bone Sonometer |
| Applicant | CooperSurgical, Inc. |
| Date Received | 1999-03-08 |
| Decision Date | 2000-01-07 |
| Notice Date | 2000-02-15 |
| PMA | P990016 |
| Supplement | S |
| Product Code | MUA |
| Docket Number | 00M-0580 |
| Advisory Committee | Radiology |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CooperSurgical, Inc. 95 Corporate Dr. trumbull, CT 06611 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990016 | Original Filing | |
| S002 | 2002-01-16 | Normal 180 Day Track |
| S001 | 2001-10-12 | Real-time Process |