Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | CRYSTALENS MODEL AT-45 MULTIPIECE SILICONE POSTERIOR CHAMBER ACCOMMODATING INTRAOCULAR LENS (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 | S001 |
Date Received | 06/28/2004 |
Decision Date | 08/16/2004 |
Product Code |
NAA |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE PHYSICIAN'S LABELING. |
|
|