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 new manufacturing facility located at plexus ea, seattle, bothell, wa.
| Device | QUS-2 CALCANEAL ULTRASONOMETER |
| Classification Name | Tester, Acoustic, Bone Quality |
| Generic Name | Tester, Acoustic, Bone Quality |
| Applicant | QUIDEL CORP. |
| Date Received | 2003-04-14 |
| Decision Date | 2003-06-19 |
| PMA | P990039 |
| Supplement | S001 |
| Product Code | NAN |
| Advisory Committee | Radiology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Express Gmp Supplement |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QUIDEL CORP. 2981 Copper Rd. santa Clara, CA |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990039 | Original Filing | |
| S001 | 2003-04-14 | Normal 180 Day Track No User Fee |