SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK
FDA premarket approval P810031/S053 · decided 2015-07-01
Approval details
- PMA number
- P810031
- Supplement
- S053
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SODIUM HYALURONATE OPHTHALMIC VISCOELASTIC DEVICES (OVD)-HEALON, HEALON GV, HEALON5, AND HEALON ULTIMATE DUAL PACK
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2015-06-03
- Decision date
- 2015-07-01
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- CHANGING FROM A MANUAL PACKAGING LINE TO AN AUTOMATED INSERTION PROCESS OF THE PRODUCT BLISTER AND/OR CANNULA FOR THE HEALON®, HEALON GV®, HEALON 5®, AND HEALON® ULTIMATE DUAL PACK.
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