PMA P980044S068
- Device
- SUPARTZ FX
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S068
- Product code
- MOZ
- Decision date
- 2026-08-26
- Classification
- Orthopedic
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- A change in the manufacturer of the A-PET thermoformed sheet used in blister packaging
Current openFDA PMA Record#
- Device
- SUPARTZ FX
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S068
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2026-08-26
- Decision code
- OK30
- Date received
- 2026-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A change in the manufacturer of the A-PET thermoformed sheet used in blister packaging