PMA P860047S027
- Device
- OCUCOAT HPMC VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S027
- Product code
- LZP
- Decision date
- 2013-01-29
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- ADDITION OF AN ALTERNATE DILUENT FOR ENDOTOXIN TESTING.
Current openFDA PMA Record#
- Device
- OCUCOAT HPMC VISCOELASTIC
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P860047
- Supplement
- S027
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2013-01-29
- Decision code
- OK30
- Date received
- 2012-12-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATE DILUENT FOR ENDOTOXIN TESTING.