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 for design changes to the delivery system as well as packaging changes to the delivery system and access kit.
| Device | Closer Vascular Sealing System (VSS) |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | REX MEDICAL, L.P. |
| Date Received | 2017-11-02 |
| Decision Date | 2018-01-31 |
| PMA | P150022 |
| Supplement | S003 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | REX MEDICAL, L.P. 555 E. North Lane Suite 5035 conshohocken, PA 19428 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150022 | Original Filing | |
| S007 | 2018-09-11 | 30-day Notice |
| S006 | ||
| S005 | 2018-05-21 | Real-time Process |
| S004 | 2018-01-08 | Special (immediate Track) |
| S003 | 2017-11-02 | Real-time Process |
| S002 | 2016-08-15 | Real-time Process |
| S001 | 2016-03-15 | Real-time Process |