PMA P080020S027

Device: Gel-One
Applicant: Seikagaku Corp.
PMA number: P080020
Supplement: S027
Product code: MOZ
Decision date: 2017-12-14
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: Changes in the storage and main weighing facilities for the hyaluronic acid component of Gel-One and commission of a back-up facility for the weighing of the hyaluronic acid component of Gel-One.

Current openFDA PMA Record#

Device: Gel-One
Applicant: Seikagaku Corp.
PMA number: P080020
Supplement: S027
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2017-12-14
Decision code: OK30
Date received: 2017-11-15
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes in the storage and main weighing facilities for the hyaluronic acid component of Gel-One and commission of a back-up facility for the weighing of the hyaluronic acid component of Gel-One.