PMA P980044S041

Device: SUPARTZ FX / VISCO-3
Applicant: Seikagaku Corp.
PMA number: P980044
Supplement: S041
Product code: MOZ
Decision date: 2017-12-14
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Change in the storage facility for the hyaluronic acid component of SUPARTZ FX and VISCO-3 and commission of back-up facilities for the weighing and preparation of components of SUPARTZ FX and VISCO-3.

Current openFDA PMA Record#

Device: SUPARTZ FX / VISCO-3
Applicant: Seikagaku Corp.
PMA number: P980044
Supplement: S041
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2017-12-14
Decision code: OK30
Date received: 2017-11-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change in the storage facility for the hyaluronic acid component of SUPARTZ FX and VISCO-3 and commission of back-up facilities for the weighing and preparation of components of SUPARTZ FX and VISCO-3.