PMA P810031S039
- Device
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S039
- Product code
- LZP
- Decision date
- 2011-07-21
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- CHANGE THE TEST METHOD FOR BIOBURDEN TESTING OF FINISHED PRODUCT PRIOR TO MOIST HEAT STERILIZATION.
Current openFDA PMA Record#
- Device
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S039
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2011-07-21
- Decision code
- OK30
- Date received
- 2011-06-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE THE TEST METHOD FOR BIOBURDEN TESTING OF FINISHED PRODUCT PRIOR TO MOIST HEAT STERILIZATION.