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 design change that was primarily to replace the open water bath with water enclosed in silicone membranes. The device, as modified, will be marketed under the trade name achilles express and is indicated for: the achilles express ultrasonometer measures ultrasound variables of the os calcis to provide a clinical measure called stiffness index. The stiffness index indicates risk of osteoporotic fracture in postmenopausal women comparable to bone mineral density (bmd) as measured by x-ray absorptiometry at the spine or hip.
| Device | ACHILLES EXPRESS ULTRASONOMETER |
| Generic Name | Bone Sonometer |
| Applicant | GE LUNAR CORP. |
| Date Received | 1999-02-16 |
| Decision Date | 1999-04-23 |
| PMA | P970040 |
| 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 | GE LUNAR CORP. 726 Heartland Trail madison, WI 53717 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970040 | Original Filing | |
| S003 | 2004-07-15 | Normal 180 Day Track No User Fee |
| S002 | 2001-05-07 | Normal 180 Day Track |
| S001 | 1999-02-16 | Real-time Process |