PMA P110007S002
- Device
- AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S002
- Product code
- LZP
- Decision date
- 2013-04-09
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- CHANGE TO THE IN-PROCESS BIOBURDEN TESTING.
Current openFDA PMA Record#
- Device
- AMO HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S002
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2013-04-09
- Decision code
- OK30
- Date received
- 2013-03-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE IN-PROCESS BIOBURDEN TESTING.