PMA P010029S038
- Device
- EUFLEXXA
- Applicant
- Ferring Pharmaceuticals, Inc.
- PMA number
- P010029
- Supplement
- S038
- Product code
- MOZ
- Decision date
- 2024-04-06
- Classification
- Orthopedic
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for updating the syringe label to include the symbol for a single barrier system with protective packaging outside.
Current openFDA PMA Record#
- Device
- EUFLEXXA
- Applicant
- Ferring Pharmaceuticals, Inc.
- PMA number
- P010029
- Supplement
- S038
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2024-04-06
- Decision code
- APPR
- Date received
- 2024-03-07
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updating the syringe label to include the symbol for a single barrier system with protective packaging outside.