PMA P960011S011
- Device
- BIOLON 1% SODIUM HYALURONATE
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S011
- Product code
- LZP
- Decision date
- 2007-09-13
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- APPROVAL FOR A CHANGE IN INFLAMMATION TESTING FOR BULK SODIUM HYALURONATE FROM OXIDATIVE BURST TESTING TO AN IL-6 ELISA METHOD.
Current openFDA PMA Record#
- Device
- BIOLON 1% SODIUM HYALURONATE
- Applicant
- Altacor , Ltd.
- PMA number
- P960011
- Supplement
- S011
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2007-09-13
- Decision code
- APPR
- Date received
- 2006-09-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN INFLAMMATION TESTING FOR BULK SODIUM HYALURONATE FROM OXIDATIVE BURST TESTING TO AN IL-6 ELISA METHOD.