PMA P110005S011
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S011
- Product code
- MOZ
- Decision date
- 2022-03-18
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Addition of an alternative filter for bulk solution filtration.
Current openFDA PMA Record#
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S011
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2022-03-18
- Decision code
- OK30
- Date received
- 2022-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative filter for bulk solution filtration.