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 to modify the magnetic resonance imaging safety labeling.
| Device | Closer Vascular Sealing System |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | REX MEDICAL, L.P. |
| Date Received | 2018-01-08 |
| Decision Date | 2018-02-07 |
| PMA | P150022 |
| Supplement | S004 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |