|
Device | HEALON ENDOCOAT 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 | P110007 |
Supplement Number | S003 |
Date Received | 04/01/2013 |
Decision Date | 05/28/2013 |
Product Code |
LZP |
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 THE USE OF A NEW RAW MATERIAL SUPPLIER FOR THE NUTRIENT SOURCE USED IN THE SODIUM HYALURONATE MANUFACTURING PROCESS. |