PMA P150022S002

Device
CLOSER VASCULAR SEALING SYSTEM
Applicant
Rex Medical, L.P.
PMA number
P150022
Supplement
S002
Product code
MGB
Decision date
2016-11-10
Classification
Device, Hemostasis, Vascular
Generic name
Device, hemostasis, vascular
Approval order statement
Approval to implement minor design modifications to the production sheath cap.

Current openFDA PMA Record#

Device
CLOSER VASCULAR SEALING SYSTEM
Applicant
Rex Medical, L.P.
PMA number
P150022
Supplement
S002
Product code
MGB
Generic name
Device, hemostasis, vascular
Decision date
2016-11-10
Decision code
APPR
Date received
2016-08-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to implement minor design modifications to the production sheath cap.