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.
| Device | BD Onclarity™ HPV Assay |
| Generic Name | Kit, Dna Detection, Human Papillomavirus |
| Applicant | BECTON, DICKINSON AND COMPANY7 Loveton Circlesparks, MD 21152 PMA NumberP160037 Supplement NumberS011 Date Received10/21/2022 Decision Date11/19/2022 Product Code MAQ Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-21 |
| Decision Date | 2022-11-19 |
| PMA | P160037 |
| Supplement | S011 |
| Product Code | MAQ |
| Advisory Committee | Microbiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BECTON, DICKINSON AND COMPANY 7 Loveton Circle sparks, MD 21152 PMA NumberP160037 Supplement NumberS011 Date Received10/21/2022 Decision Date11/19/2022 Product Code MAQ Advisory Committee Microbiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement a Modification To The Circuit Board Layout On The Instrumentation Module |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160037 | Original Filing | |
| S013 | 2022-11-21 | 30-day Notice |
| S012 | ||
| S011 | 2022-10-21 | 30-day Notice |
| S010 | 2021-10-28 | Real-time Process |
| S009 | 2020-09-14 | 30-day Notice |
| S008 | ||
| S007 | 2020-07-06 | 30-day Notice |
| S006 | 2020-02-21 | 30-day Notice |
| S005 | ||
| S004 | ||
| S003 | 2019-08-21 | Normal 180 Day Track No User Fee |
| S002 | 2019-02-26 | Real-time Process |
| S001 | 2018-04-27 | 135 Review Track For 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00382904440893 | P160037 | 000 |
| 00382904419905 | P160037 | 000 |
| 00382904440886 | P160037 | 000 |
| 00382904429577 | P160037 | 000 |
| 00382904429676 | P160037 | 000 |
| 00382904438371 | P160037 | 000 |
| 00382904440879 | P160037 | 000 |
| 00382904440725 | P160037 | 005 |
| 00382904440749 | P160037 | 005 |
| 00382904439903 | P160037 | 005 |
| 00382904439880 | P160037 | 005 |
| 00382904440831 | P160037 | 005 |
| 00382904440756 | P160037 | 005 |
| 00382904453282 | P160037 | 008 |
| 00382904453299 | P160037 | 008 |
| 00382904454364 | P160037 | 017 |
| 00382904454166 | P160037 | 017 |