PMA P030002S005
- Device
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P030002
- Supplement
- S005
- Product code
- NAA
- Decision date
- 2005-09-26
- Generic name
- Lens, intraocular, accommodative
- Approval order statement
- APPROVAL FOR CHANGES IN THE ?RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES? SECTION OF THE PHYSICIANS LABELING.
Current openFDA PMA Record#
- Device
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL)
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P030002
- Supplement
- S005
- Product code
- NAA
- Generic name
- Lens, intraocular, accommodative
- Decision date
- 2005-09-26
- Decision code
- APPR
- Date received
- 2005-08-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES IN THE ?RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES? SECTION OF THE PHYSICIANS LABELING.