PMA P030002S006
- Device
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P030002
- Supplement
- S006
- Product code
- NAA
- Decision date
- 2006-03-03
- Generic name
- Lens, intraocular, accommodative
- Approval order statement
- APPROVAL FOR UPDATED PHYSICIAN LABELING WITH 3-YEAR CLINICAL DATA.
Current openFDA PMA Record#
- Device
- CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS
- Applicant
- Bausch & Lomb, Inc.
- PMA number
- P030002
- Supplement
- S006
- Product code
- NAA
- Generic name
- Lens, intraocular, accommodative
- Decision date
- 2006-03-03
- Decision code
- APPR
- Date received
- 2005-10-20
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR UPDATED PHYSICIAN LABELING WITH 3-YEAR CLINICAL DATA.