| Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
| |
| Trade Name | HEALON ENDOCOAT OPVISCOSURGICAL OPHTHALMIC DEVICE (OVD) (3% SODIUM HYALURONATE) |
|---|
| Classification Name | aid, surgical, viscoelastic |
|---|
| Regulation Number | 886.4275 |
|---|
| Applicant | ABBOTT MEDICAL OPTICS INC |
|---|
| PMA Number | P110007 |
|---|
| Date Received | 02/22/2011 |
|---|
| Decision Date | 07/02/2012 |
|---|
| Product Code | |
| Docket Number | 12M-0734 |
|---|
| Notice Date | 07/16/2012 |
|---|
| Advisory Committee |
Ophthalmic |
|---|
| Clinical Trials |
NCT00972621
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product |
No
|
|---|
| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
|---|
Approval Order Statement
Approval for the healon endocoat ovd. Healon endocoat ovd is an ophthalmic viscoelastic containing 3% sodium hyaluronate indicated for use as a surgical aid in patients undergoing ophthalmic anterior segment surgical procedures including, cataract surgery with an intraocular lens, cataract surgery without an intraocular lens, and secondary intraocular lens implantation. Healon endocoat ovd maintains a deep chamber during anterior segment surgery, enhances visualization during the surgical procedure and protects the corneal endothelium and other ocular tissue. The viscoelasticity of the solution maintains the normal position of the vitreous face and prevents formation of a flat chamber during surgery. It may also be used to coat intraocular lenses and insertion instruments prior to intraocular lens implantation. |
| Approval Order |
Approval Order
|
| Supplements: |
S001 S002 S004 |
|
|
