DevicePMAs@therightstef:P090022_S022 11 Projects
|
Approval to reduce the size of the secondary packaging which houses the pouched intraocular lenses, label and directions for use (dfu). the device, as modified, will be marketed under the trade name softec hd, softec i, and softec hdo and is indicated for the replacement of the human crystalline lens following phacoemulsificaton cataract removal inadults over the age of 21.
|
Annnotations
- Denotations: 4
- Blocks: 0
- Relations: 0