- Device
- HEALON ENDOCOAT OPTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S006
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2015-04-02
- Decision code
- OK30
- Date received
- 2015-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFY THE QUALITY CONTROL TEST METHODS AND/OR ACCEPTANCE CRITERIA ASSOCIATED WITH THE ABBOTT MEDICAL OPTICS (AMO) SODIUM HAYALURONATE (NAHY) SPECIFICATIONS.