PMA P810025S022
- Device
- AMVISC & AMVISC PLUS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S022
- Product code
- LZP
- Decision date
- 2003-08-19
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- APPROVAL FOR A CHANGE IN THE USE OF HYALURONIC ACID POWDER AS AN ALTERNATE RAW MATERIAL AND FOR THE USE OF AN ALTERNATE ENDOTOXIN TEST.
Current openFDA PMA Record#
- Device
- AMVISC & AMVISC PLUS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P810025
- Supplement
- S022
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2003-08-19
- Decision code
- APPR
- Date received
- 2003-04-29
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE IN THE USE OF HYALURONIC ACID POWDER AS AN ALTERNATE RAW MATERIAL AND FOR THE USE OF AN ALTERNATE ENDOTOXIN TEST.