PMA P110005S004
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S004
- Product code
- MOZ
- Decision date
- 2020-07-10
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Approval for inclusion of the routine use of bioindicators to monitor efficacy of the sterilization cycle for every batch of GELSYN-3.
Current openFDA PMA Record#
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S004
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-07-10
- Decision code
- APPR
- Date received
- 2020-06-29
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for inclusion of the routine use of bioindicators to monitor efficacy of the sterilization cycle for every batch of GELSYN-3.