PMA P950027S015
- Device
- HYALGAN
- Applicant
- Fidia Farmaceutici S.P.A.
- PMA number
- P950027
- Supplement
- S015
- Product code
- MOZ
- Decision date
- 2016-08-26
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Change in the filter cartridge used during manufacturing of Hyalgan.
Current openFDA PMA Record#
- Device
- HYALGAN
- Applicant
- Fidia Farmaceutici S.P.A.
- PMA number
- P950027
- Supplement
- S015
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2016-08-26
- Decision code
- OK30
- Date received
- 2016-08-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the filter cartridge used during manufacturing of Hyalgan.