|
Device | POSTERIOR CHAMBER INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | BAUSCH & LOMB 1400 NORTH GOODMAN ST. ROCHESTER, NY 14609-3547 |
PMA Number | P790027 |
Supplement Number | S061 |
Date Received | 10/29/1998 |
Decision Date | 12/28/1998 |
Withdrawal Date
|
11/26/2008 |
Product Code |
HQL |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for use of an alternate sterilization chamber at Griffith MicroScience. |