Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | IOLTECH, S.A. 64 SCHOOSETT STREET PENBROKE, MA 02359-1882 |
PMA Number | P960036 |
Supplement Number | S007 |
Date Received | 07/08/2002 |
Decision Date | 07/26/2002 |
Withdrawal Date
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10/12/2006 |
Product Code |
HQL |
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 ADDITION OF AN ALTERNATE STEAM STERILIZER FOR THE TERMINAL STERILIZATION OF THE CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS. |
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