Atlas FDA

ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)

FDA premarket approval P880090/S024 · decided 2008-06-09

Approval details

PMA number
P880090
Supplement
S024
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
ANTERIOR CHAMBER POLYMETHYLMETHACRYLATE (PMMA) INTRAOCULAR LENSES (IOLS)
Generic name
intraocular lens
Applicant
Bausch & Lomb, Inc.
Date received
2008-04-04
Decision date
2008-06-09
Days to decision
66 days
Decision code
APPR
Product code
HQL
Advisory committee
Ophthalmic
Expedited review
No
Location
Irvine, CA
Statement
APPROVAL TO CHANGE THE LENS CARRIER TO THE ROTARY CAP CARRIER, PN/ 14937-62, FOR THE ANTERIOR CHAMBER IOLS.

Class III intelligence, same tools

PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.

510(k) clearances by this applicant

RecordFirmDate
Bausch + Lomb PreVue Inserter for enVista Preloaded (K192005)Bausch & Lomb, Inc.2019-10-04
Crystalsert Lens Delivery System (K173480)Bausch & Lomb, Inc.2017-12-11
Bausch + Lomb Injector System (K151102)Bausch & Lomb, Inc.2015-05-22
BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS, BAUSCH + LOMB PROCOMFORT (SAMFILCON A) CONTACT LENS FOR PRESBYOPIA, (K131208)Bausch & Lomb, Inc.2013-09-11
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI (K122575)Bausch & Lomb, Inc.2012-12-20
BAUSCH & LOMB IOL INJECTOR (K113852)Bausch & Lomb, Inc.2012-09-28
OCD04 3% HYDROGEN PEROXIDE CLEANING AND DISINFECTING SOULTION (K112909)Bausch & Lomb, Inc.2012-04-30
EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION (K111877)Bausch & Lomb, Inc.2012-01-24