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 revised protocol for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p160052.
| Device | PartoSure Test |
| Classification Name | Placental Alpha Microglobulin-1 Immunoassay |
| Generic Name | Placental Alpha Microglobulin-1 Immunoassay |
| Applicant | QIAGEN Inc |
| Date Received | 2018-05-11 |
| Decision Date | 2019-10-11 |
| PMA | P160052 |
| Supplement | S001 |
| Product Code | QBB |
| Advisory Committee | Toxicology |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN Inc 19300 Germantown Road germantown, MD 20874 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160052 | Original Filing | |
| S001 | 2018-05-11 | Normal 180 Day Track No User Fee |