|
Device | AMO TECNIS ACRYLIC INTRAOCULAR LENS (IOL) MODEL ZA9003 |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990080 |
Supplement Number | S036 |
Date Received | 11/14/2011 |
Decision Date | 04/23/2012 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES. |