PMA P110005S006
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S006
- Product code
- MOZ
- Decision date
- 2020-10-08
- Generic name
- Acid, hyaluronic, intraarticular
- Approval order statement
- Change to the bacterial endotoxins (BE) acceptance limit for the glass syringe associated with change in BE test method.
Current openFDA PMA Record#
- Device
- GELSYN-3
- Applicant
- Ibsa Institut Biochimique SA
- PMA number
- P110005
- Supplement
- S006
- Product code
- MOZ
- Generic name
- Acid, hyaluronic, intraarticular
- Decision date
- 2020-10-08
- Decision code
- OK30
- Date received
- 2020-09-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the bacterial endotoxins (BE) acceptance limit for the glass syringe associated with change in BE test method.