|
Device | AMO REZOOM INTRAOCULAR LENS (IOL) MODEL NXG1 |
Generic Name | Lens, multifocal intraocular |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P960028 |
Supplement Number | S035 |
Date Received | 11/14/2011 |
Decision Date | 04/23/2012 |
Product Code |
MFK |
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 |
Approval Order Statement APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES. |