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 | RAYNER C-FLEX 570C AND C-FLEX ASPHERIC 970C INTRAOCULAR LENSES |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | RAYNER INTRAOCULAR LENSES LTD. 1-2 SACKVILLE TRADING ESTATE, SACKVILLE ROAD HOVE, EAST SUSSEX BN3 7 |
PMA Number | P060011 |
Supplement Number | S003 |
Date Received | 02/06/2012 |
Decision Date | 03/08/2012 |
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 |
Recalls | CDRH Recalls |
Approval Order Statement SOFTWARE UPGRADE TO THE OPTICAL MEASURING EQUIPMENT. |
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