|
Device | STAAR SURGICAL AQUAFLOW COLLAGEN GLAUCOMA DRAINAGE DEVICE |
Generic Name | Intraocular pressure lowering implant |
Applicant | STARR SURGICAL CO. 1911 WALKER AVE. MONROVIA, CA 91016 |
PMA Number | P000026 |
Supplement Number | S001 |
Date Received | 07/23/2008 |
Decision Date | 09/10/2008 |
Withdrawal Date
|
07/01/2020 |
Product Code |
OGO |
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 ADDING IN HOUSE LIMULUS AMEBOCYTE LYSATE TESTING. |