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 | Cardiva VASCADE Family |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | CARDIVA MEDICAL, INC.2900 Lakeside Drivesuite 160santa Clara, CA 95054 PMA NumberP120016 Supplement NumberS030 Date Received10/11/2022 Decision Date11/08/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-10-11 |
| Decision Date | 2022-11-08 |
| PMA | P120016 |
| Supplement | S030 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | CARDIVA MEDICAL, INC. 2900 Lakeside Drive suite 160 santa Clara, CA 95054 PMA NumberP120016 Supplement NumberS030 Date Received10/11/2022 Decision Date11/08/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Alternative To Batch Testing For Bacterial Endotoxins |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120016 | Original Filing | |
| S030 | 2022-10-11 | 30-day Notice |
| S029 | ||
| S028 | 2021-02-08 | Normal 180 Day Track |
| S027 | 2019-07-08 | Normal 180 Day Track |
| S026 | 2018-11-23 | Normal 180 Day Track No User Fee |
| S025 | 2018-07-10 | Real-time Process |
| S024 | 2018-05-30 | Panel Track |
| S023 | 2017-03-20 | 30-day Notice |
| S022 | 2017-01-17 | 30-day Notice |
| S021 | 2016-11-04 | Normal 180 Day Track |
| S020 | 2016-06-03 | Real-time Process |
| S019 | 2016-01-07 | 30-day Notice |
| S018 | 2015-11-16 | 30-day Notice |
| S017 | 2015-11-03 | 135 Review Track For 30-day Notice |
| S016 | 2015-06-29 | Special (immediate Track) |
| S015 | 2015-05-18 | Real-time Process |
| S014 | 2015-04-03 | Normal 180 Day Track No User Fee |
| S013 | 2015-03-12 | 30-day Notice |
| S012 | 2015-03-03 | 30-day Notice |
| S011 | 2015-02-25 | 30-day Notice |
| S010 | 2015-02-18 | 30-day Notice |
| S009 | 2015-02-09 | 30-day Notice |
| S008 | 2014-12-12 | 30-day Notice |
| S007 | 2014-10-20 | 30-day Notice |
| S006 | 2014-09-29 | 30-day Notice |
| S005 | 2014-08-18 | 135 Review Track For 30-day Notice |
| S004 | 2014-08-18 | Real-time Process |
| S003 | 2014-06-27 | 30-day Notice |
| S002 | 2014-03-31 | Real-time Process |
| S001 | 2014-03-18 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| M729700580I1 | P120016 | 000 |
| M729700500DX1 | P120016 | 000 |
| M729800612C2 | P120016 | 024 |
| M7298001012XL2 | P120016 | 029 |