PMA P980044S047

Device: SUPARTZ FX and VISCO-3
Applicant: Seikagaku Corp.
PMA number: P980044
Supplement: S047
Product code: MOZ
Decision date: 2018-08-16
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Approval for a change to the shape of the finger grip component of the syringe container closure system for SUPARTZ FX and VISCO-3 and for modifications to assembly and blister packaging equipment.

Current openFDA PMA Record#

Device: SUPARTZ FX and VISCO-3
Applicant: Seikagaku Corp.
PMA number: P980044
Supplement: S047
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2018-08-16
Decision code: APPR
Date received: 2018-05-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for a change to the shape of the finger grip component of the syringe container closure system for SUPARTZ FX and VISCO-3 and for modifications to assembly and blister packaging equipment.