PMA P840064S040
- Device
- VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S040
- Product code
- LZP
- Decision date
- 2009-08-13
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- APPROVAL FOR AN ALTERNATE CLEAN ROOM FOR ASEPTIC FILLING AS PART OF A GENERAL MANUFACTURING PLANT EXPANSION.
Current openFDA PMA Record#
- Device
- VISCOAT/DUOVISC/DISCOVISC OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Alcon Laboratories
- PMA number
- P840064
- Supplement
- S040
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2009-08-13
- Decision code
- APPR
- Date received
- 2009-02-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE CLEAN ROOM FOR ASEPTIC FILLING AS PART OF A GENERAL MANUFACTURING PLANT EXPANSION.