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 | Healon PRO, Healon GV PRO, Healon 5 PRO Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD) |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive suite 200 Irvine, CA 92618 |
PMA Number | P810031 |
Supplement Number | S070 |
Date Received | 04/01/2021 |
Decision Date | 02/16/2022 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for an alternative terminal sterilization modality, ethylene oxide, for the Ophthalmic Viscoelastic Devices (OVDs), Healon® PRO, Healon 5® PRO and Healon GV® PRO, in final finished packaging. |
|
|