PMA P810031S062
- Device
- Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S062
- Product code
- LZP
- Decision date
- 2017-07-20
- Classification
- Aid, Surgical, Viscoelastic
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Approval order statement
- Change in the composition of the coating used inside the dissolution chambers.
Current openFDA PMA Record#
- Device
- Healon, Healo GV, Healon 5, Healon Ulrimate Dual Pack, Healon Duet Dual Pack products
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- PMA number
- P810031
- Supplement
- S062
- Product code
- LZP
- Generic name
- AID, SURGICAL, VISCOELASTIC
- Decision date
- 2017-07-20
- Decision code
- OK30
- Date received
- 2017-06-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the composition of the coating used inside the dissolution chambers.