PMA P880031S016

Device
HEALON D SODIUM HYALURONATE SOLUTION
Applicant
Abbott Medical Optics, Inc.
PMA number
P880031
Supplement
S016
Product code
LZP
Decision date
2009-02-18
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
APPROVAL TO CHANGE THE PH PRODUCT SPECIFICATION RANGE FOR HEALON D FROM 7.1 ¿ 7.5 TO 6.8 ¿ 7.6.

Current openFDA PMA Record#

Device
HEALON D SODIUM HYALURONATE SOLUTION
Applicant
Abbott Medical Optics, Inc.
PMA number
P880031
Supplement
S016
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2009-02-18
Decision code
APPR
Date received
2009-01-08
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL TO CHANGE THE PH PRODUCT SPECIFICATION RANGE FOR HEALON D FROM 7.1 ¿ 7.5 TO 6.8 ¿ 7.6.