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 | The SENSAR 1-Piece IOL with SmartLOAD Delivery Technology, The TECNIS 1-Piece IOL with SmartLOAD Delivery Technology, Th |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P980040 |
Supplement Number | S144 |
Date Received | 12/20/2021 |
Decision Date | 02/14/2022 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at AMO Groningen BV, Groningen, Groningen, 9728, NX, Netherlands as an alternative manufacturing and sterilization facility for the following with SmartLOAD Delivery Technology: SENSAR 1-Piece IOL, TECNIS 1-Piece IOL, TECNIS OptiBlue 1-Piece IOL and TECNIS Eyhance 1-Piece IOL. |
|
|