HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
FDA premarket approval P110007/S004 · decided 2013-05-08
Approval details
- PMA number
- P110007
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Date received
- 2013-04-01
- Decision date
- 2013-05-08
- Days to decision
- 37 days
- Decision code
- OK30
- Product code
- LZP
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- TRANSFER THE PREPARATION OF THE WORKING CELL BANK TO LIFECORE BIOMEDICAL.
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