- Device
- OCUCOAT(2%HYDROXYPROPYLMETHYLCELLULOSE SOLUTION)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S012
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2003-04-16
- Decision code
- OK30
- Date received
- 2003-03-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE FREQUENCY OF THE FOLLOWING INCOMING INSPECTION TESTS: HPMC CONTENT, TOTAL CHLORIDES, OSMOLARITY, PARTICULATES, PROTEIN, DENSITY, HPMC VOLUME, PH AND VISCOSITY.