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 for a software update from v4. 2. 0 to v4. 2. 1 and a new phantom (qa coupler).
| Device | MC CUE PLC CUBA CLINICAL ULTRASONIC BONE SONOMETRY SYSTEM |
| Generic Name | Bone Sonometer |
| Applicant | CooperSurgical, Inc. |
| Date Received | 2001-10-12 |
| Decision Date | 2001-11-08 |
| PMA | P990016 |
| Supplement | S001 |
| Product Code | MUA |
| Advisory Committee | Radiology |
| Supplement Type | Real-time Process |
| 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 |