PMA P110005S001
- Device
- Gel-Syn™
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S001
- Product code
- MOZ
- Decision date
- 2016-05-23
- Classification
- Acid, Hyaluronic, Intraarticular
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for the addition of a needle to the Gel-Syn packaging configuration
Current openFDA PMA Record#
- Device
- Gel-Syn™
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S001
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2016-05-23
- Decision code
- APPR
- Date received
- 2016-03-25
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the addition of a needle to the Gel-Syn packaging configuration