PMA P110007S001
- Device
- ABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S001
- Product code
- LZP
- Decision date
- 2012-10-09
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE SYRINGE AND CARTON ASSEMBLIES.
Current openFDA PMA Record#
- Device
- ABBOTT MEDICAL OPTICS (AMO) HEALON ENDOCOAT OPHTHALMIC VISCOSURGICAL DEVICE
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P110007
- Supplement
- S001
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2012-10-09
- Decision code
- OK30
- Date received
- 2012-09-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM A MANUAL TO AN AUTOMATED PROCESS FOR THE SYRINGE AND CARTON ASSEMBLIES.