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.
Add an alternate supplier of the critical component solid phase receptacle (spr-pm) for the vidas® total psa and free psa products.
| Device | VIDAS FREE PSA (FPSA) ASSAY |
| Generic Name | Test, Prostate Specific Antigen, Free, (noncomplexed) To Distinguish Prostate Cancer From Benign Conditions |
| Applicant | BioMerieux, Inc. |
| Date Received | 2012-01-09 |
| Decision Date | 2012-02-08 |
| PMA | P080008 |
| Supplement | S001 |
| Product Code | MTG |
| Advisory Committee | Immunology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | bioMerieux, Inc. 595 Anglum Rd. hazelwood, MO 63042 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P080008 | Original Filing | |
| S002 | 2012-10-11 | Real-time Process |
| S001 | 2012-01-09 | 30-day Notice |