|
Device | HEALON D SODIUM HYALURONATE SOLUTION |
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 | S016 |
Date Received | 01/08/2009 |
Decision Date | 02/18/2009 |
Withdrawal Date
|
03/03/2011 |
Product Code |
LZP |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL TO CHANGE THE PH PRODUCT SPECIFICATION RANGE FOR HEALON D FROM 7.1 ¿ 7.5 TO 6.8 ¿ 7.6. |