PMA P990014
- Device
- Hydroview Composite Hydrogel Foldable Uv-absorbing
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P990014
- Decision date
- 1999-11-12
Current openFDA PMA Record
- Device
- MERIDIAN INTRAOCULAR LENSES
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P990014
- Supplement
- S005
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2008-05-02
- Decision code
- OK30
- Date received
- 2008-04-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE LIMULUS AMEBOCYTE LYSATE (LAL) TESTING METHOD AND A CHANGE IN THE SITE FOR THE LAL FINAL PRODUCT TESTING TO BAUSCH & LOMB, INC.?S CLEARWATER, FLORIDA FACILITY.