This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the cubaclinical data controller (data controller). The data controller is a hand-held control device that enables the user to operate the cubaclinical without the computer and the software for data analysis. The modifications to the bone sonometer consist of the integration of the data controller and associated software, simple replacement of the cubaclinical serial connector, and data controller operating instructions. The results are displayed on an lcd screen display and the printout shows a graphical display of patient data.
| Device | MCCUE CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM |
| Generic Name | Bone Sonometer |
| Applicant | CooperSurgical, Inc. |
| Date Received | 2002-01-16 |
| Decision Date | 2002-03-28 |
| PMA | P990016 |
| Supplement | S002 |
| Product Code | MUA |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CooperSurgical, Inc. 95 Corporate Dr. trumbull, CT 06611 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990016 | Original Filing | |
| S002 | 2002-01-16 | Normal 180 Day Track |
| S001 | 2001-10-12 | Real-time Process |