|
Device | CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR (IOL) |
Generic Name | Lens, intraocular, accommodative |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S005 |
Date Received | 08/23/2005 |
Decision Date | 09/26/2005 |
Product Code |
NAA |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR CHANGES IN THE ?RECOMMENDATIONS FOR MAXIMIZING PATIENT OUTCOMES? SECTION OF THE PHYSICIANS LABELING. |