PMA P950027S004
- Device
- HYALGAN
- Applicant
- Fidia Farmaceutici S.P.A.
- PMA number
- P950027
- Supplement
- S004
- Product code
- MOZ
- Decision date
- 2000-08-30
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- APPROVAL TO MODIFY LABELING, ADDING INFORMATION ABOUT THE CURRENT CLINICAL EXPERIENCE OF THE DEVICE.
Current openFDA PMA Record#
- Device
- HYALGAN
- Applicant
- Fidia Farmaceutici S.P.A.
- PMA number
- P950027
- Supplement
- S004
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2000-08-30
- Decision code
- APPR
- Date received
- 1998-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO MODIFY LABELING, ADDING INFORMATION ABOUT THE CURRENT CLINICAL EXPERIENCE OF THE DEVICE.