PMA P980044S037
- Device
- Supartz Device Family
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S037
- Product code
- MOZ
- Decision date
- 2017-03-21
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Update microbiological incubators used for quality control testing and environmental monitoring of products for SUPARTZ FX and VISCO-3.
Current openFDA PMA Record#
- Device
- Supartz Device Family
- Applicant
- Seikagaku Corp.
- PMA number
- P980044
- Supplement
- S037
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2017-03-21
- Decision code
- OK30
- Date received
- 2017-02-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update microbiological incubators used for quality control testing and environmental monitoring of products for SUPARTZ FX and VISCO-3.