PMA P110005S009
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S009
- Product code
- MOZ
- Decision date
- 2021-09-02
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for addition of an alternative supplier of a raw hyaluronic acid salt material component.
Current openFDA PMA Record#
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S009
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2021-09-02
- Decision code
- APPR
- Date received
- 2021-03-31
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for addition of an alternative supplier of a raw hyaluronic acid salt material component.