PMA P110005S007
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S007
- Product code
- MOZ
- Decision date
- 2020-12-28
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- a change in the holding times for which filtered solution and bulk solution are kept during the manufacturing process.
Current openFDA PMA Record#
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S007
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-12-28
- Decision code
- OK30
- Date received
- 2020-12-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change in the holding times for which filtered solution and bulk solution are kept during the manufacturing process.