HEALON D

Aid, Surgical, Viscoelastic

FDA Premarket Approval P880031 S014

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.

Pre-market Approval Supplement Details

Approval to move the manufacture of vitrax from the allergan facility in westport, ireland to the amo uppsala facility in sweden, for a 0. 4 ml fill volume in addition to the currently approved 0. 65 ml fill volume, and re-brand the dispersive vitrax product manufactured in uppsala, sweden as healon d (dispersive).

DeviceHEALON D
Classification NameAid, Surgical, Viscoelastic
Generic NameAid, Surgical, Viscoelastic
ApplicantABBOTT MEDICAL OPTICS INC
Date Received2007-02-15
Decision Date2008-08-22
PMAP880031
SupplementS014
Product CodeLZP
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT MEDICAL OPTICS INC 1700 E. St. Andrew Place santa Ana, CA 92705

Supplemental Filings

Supplement NumberDateSupplement Type
P880031Original Filing
S016 2009-01-08 Real-time Process
S015 2008-08-20 30-day Notice
S014 2007-02-15 Normal 180 Day Track
S013 1999-10-15 Real-time Process
S012 1998-02-02 Real-time Process
S011 1995-12-26 Normal 180 Day Track
S010 1995-11-24 Normal 180 Day Track
S009 1995-10-17 Normal 180 Day Track
S008 1994-06-02 Special (immediate Track)
S007 1992-08-21 Normal 180 Day Track
S006 1992-07-02 Normal 180 Day Track
S005 1992-01-15 Normal 180 Day Track
S004 1991-06-12 Normal 180 Day Track
S003
S002
S001

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