|
Device | CRYSTALENS MODEL AT-45 ACCOMMODATING INTRACULAR LENS |
Generic Name | Lens, intraocular, accommodative |
Regulation Number | 886.3600 |
Applicant | Bausch & Lomb, Inc. 50 Technology Drive Irvine, CA 92618 |
PMA Number | P030002 |
Supplement Number | S006 |
Date Received | 10/20/2005 |
Decision Date | 03/03/2006 |
Product Code |
NAA |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR UPDATED PHYSICIAN LABELING WITH 3-YEAR CLINICAL DATA. |