PMA P160057S001

Device
TriVisc
Applicant
Channel-Markers Medical, LLC
PMA number
P160057
Supplement
S001
Product code
MOZ
Decision date
2020-06-07
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Approval for revision of the instructions for administration of TriVisc to help prevent any leakage of the product during administration.

Current openFDA PMA Record#

Device
TriVisc
Applicant
Channel-Markers Medical, LLC
PMA number
P160057
Supplement
S001
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2020-06-07
Decision code
APPR
Date received
2020-05-08
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revision of the instructions for administration of TriVisc to help prevent any leakage of the product during administration.