Approval for the alcon online toric iol calculator which is a modification of the toric iol calculators. The device, as modified, will be marketed under the trade name alcon online toric iol calculator for the acrysof toric and iq toric iols. The acrysof toric and iq toric posterior chamber intraocular lenses are intended for primary implantation in the capsular bag of the eye for visual correction of aphakia and pre-existing corneal astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia, who desire improved uncorrected distance vision, reduction of residual refractive cylinder and increased spectacle independence for distance vision.
| Device | HOME ACCESS HEPATITIS C CHECK |
| Classification Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Generic Name | Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus |
| Applicant | HOME ACCESS HEALTH CORP. |
| Date Received | 2015-09-22 |
| Decision Date | 2015-12-09 |
| PMA | P980046 |
| Supplement | S009 |
| Product Code | MZO |
| Advisory Committee | Microbiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOME ACCESS HEALTH CORP. 2401 W. Hassell suite 1510 hoffman Estates, IL 60195-5200 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P980046 | | Original Filing |
| S009 |
2015-09-22 |
Normal 180 Day Track |
| S008 |
2011-08-01 |
30-day Notice |
| S007 |
2004-12-03 |
30-day Notice |
| S006 |
2003-05-28 |
Normal 180 Day Track No User Fee |
| S005 |
2002-10-24 |
Normal 180 Day Track |
| S004 |
2001-02-23 |
Normal 180 Day Track |
| S003 | | |
| S002 |
2000-03-23 |
30-day Notice |
| S001 | | |
NIH GUDID Devices