|
Device | VITRAX/HEALON D SODIUM HYALURONATE SOLUTION OPHTHALMIC VISCOSURGICAL DEVICES |
Generic Name | AID, SURGICAL, VISCOELASTIC |
Regulation Number | 886.4275 |
Applicant | ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place Santa Ana, CA 92705 |
PMA Number | P880031 |
Supplement Number | S015 |
Date Received | 08/20/2008 |
Decision Date | 09/19/2008 |
Withdrawal Date
|
03/03/2011 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement IMPLEMENTATION OF A NEW WATER SYSTEM. |