Approval for the 14f manta vascular closure device. The device is indicated for closure of femoral arterial access sites following the use of 10-14f devices or sheaths (maximum od/profile of 18f), and the 18f manta vascular closure device is indicated for closure of femoral arterial access sites following the use of 15-18f devices or sheaths (maximum od/profile of 25f).
| Device | MANTA Vascular Closure |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Essential Medical, Inc. |
| Date Received | 2018-07-09 |
| Decision Date | 2019-02-01 |
| PMA | P180025 |
| Supplement | S |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Essential Medical, Inc. 260 Sierra Drive suite 120 exton, PA 19341 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180025 | | Original Filing |
| S009 |
2021-02-10 |
Normal 180 Day Track |
| S008 |
2020-08-21 |
30-day Notice |
| S007 |
2020-05-04 |
30-day Notice |
| S006 |
2020-01-06 |
Real-time Process |
| S005 |
2019-07-23 |
30-day Notice |
| S004 | | |
| S003 | | |
| S002 |
2019-04-18 |
30-day Notice |
| S001 | | |
NIH GUDID Devices