PMA P080020S053

Device: Gel-One
Applicant: Seikagaku Corp.
PMA number: P080020
Supplement: S053
Product code: MOZ
Decision date: 2025-01-17
Classification: Orthopedic
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: The sharing of the existing h-HAD (Gel-One intermediate) manufacturing equipment in Preparation Building-1 in the SKK Takahagi Plant currently used to manufacture Hyaluronic Acid extracted from chicken combs (existing h-Had) along with h-HAD made from Hyaluronic Acid extracted from bacterial fermentation (FHA-h-HAD). The existing validated cleaning method will be used for the shared equipment to assure the cleanliness and minimize risks of cross-contamination of FHA-h-HAD to the existing h-HAD production.

Current openFDA PMA Record#

Device: Gel-One
Applicant: Seikagaku Corp.
PMA number: P080020
Supplement: S053
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2025-01-17
Decision code: OK30
Date received: 2024-12-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The sharing of the existing h-HAD (Gel-One intermediate) manufacturing equipment in Preparation Building-1 in the SKK Takahagi Plant currently used to manufacture Hyaluronic Acid extracted from chicken combs (existing h-Had) along with h-HAD made from Hyaluronic Acid extracted from bacterial fermentation (FHA-h-HAD). The existing validated cleaning method will be used for the shared equipment to assure the cleanliness and minimize risks of cross-contamination of FHA-h-HAD to the existing h-HAD production.