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. |
|
Device | TECNIS ACRYLIC IOLS |
Generic Name | intraocular lens |
Regulation Number | 886.3600 |
Applicant | Johnson & Johnson Surgical Vision, Inc. 31 Technology Drive Suite 200 Irvine, CA 92618 |
PMA Number | P990080 |
Supplement Number | S027 |
Date Received | 09/24/2007 |
Decision Date | 10/24/2007 |
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 INCREASE IN THE FREQUENCY OF MICROBIOLOGICAL MONITORING FOR THE WATER SYSTEM IN THE ADVANCED MEDICAL OPTICS (AMO) ANASCO, PUERTO RICO FACILITY. |
|
|