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 | TECNIS 1-PIECE IOL, MODEL:ZCB00,TECNIS MULTIFOCAL 1-PIECE IOL, MODEL:ZMB00,TECNIS TORIC 1-PIECE IOL,MODELS:ZCT150, ZCT22 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S055 |
Date Received | 12/03/2014 |
Decision Date | 12/31/2014 |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ALTERNATE SUPPLIER FOR AN INTRAOCULAR PACKAGING COMPONENT. |
|
|