PMA P150022S004
- Device
- Closer Vascular Sealing System
- Applicant
- Rex Medical, L.P.
- PMA number
- P150022
- Supplement
- S004
- Product code
- MGB
- Decision date
- 2018-02-07
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- Approval to modify the magnetic resonance imaging safety labeling.
Current openFDA PMA Record#
- Device
- Closer Vascular Sealing System
- Applicant
- Rex Medical, L.P.
- PMA number
- P150022
- Supplement
- S004
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2018-02-07
- Decision code
- APPR
- Date received
- 2018-01-08
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval to modify the magnetic resonance imaging safety labeling.