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.
Approval for a trade name change of the memorylens iol. The device will be marketed under the trade name cv232 sre pre-rolled acrylic intraocular lens and is indicated for primary implantation for the visual correction of aphakia in patients 60 years of age of older where a cataractous lens has been removed by an extracapsular cataract extraction method. The lens is intended for placement in the capsular bag.
Device | CV232 SRE PRE-ROLLED ACRYLIC INTRAOCULAR LENS |
Classification Name | Intraocular Lens |
Generic Name | Intraocular Lens |
Applicant | IOLTECH, S.A. |
Date Received | 2002-06-06 |
Decision Date | 2002-06-20 |
PMA | P960036 |
Supplement | S006 |
Product Code | HQL |
Advisory Committee | Ophthalmic |
Supplement Type | Real-time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
Expedited Review | No |
Combination Product | No |
Applicant Address | IOLTECH, S.A. 64 Schoosett Street penbroke, MA 02359-1882 |
Supplement Number | Date | Supplement Type |
---|---|---|
P960036 | Original Filing | |
S007 | 2002-07-08 | 30-day Notice |
S006 | 2002-06-06 | Real-time Process |
S005 | 2001-12-21 | Normal 180 Day Track |
S004 | 2000-09-18 | Normal 180 Day Track |
S003 | 2000-08-31 | Normal 180 Day Track |
S002 | 2000-07-17 | Normal 180 Day Track |
S001 | 1999-08-23 | Real-time Process |