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. |
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Device | Sodium Hyaluronate OphthalmicViscoelastic Devices (OVD), Healon PRO, Healon GV PRO, Healon5 PRO and Healon Duet PRO Dual |
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 | S072 |
Date Received | 06/02/2021 |
Decision Date | 07/13/2021 |
Product Code |
LZP |
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 Change from sterility testing to parametric release for product release of the Healon® PRO (packaged individually and in the Healon® Duet PRO Dual Pack), Healon5® PRO and Healon® GV PRO ophthalmic viscoelastic devices (OVDs), in their primary glass syringe packaging, following moist heat steam sterilization. |
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