PMA P860047S025

Device
OCUCOAT SYRINGE PRODUCT
Applicant
Bausch & Lomb, Inc.
PMA number
P860047
Supplement
S025
Product code
LZP
Decision date
2012-02-03
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
APPROVAL FOR AN ALTERNATE ELASTOMERIC TIP CAP MATERIAL (FM27) AND THE ADDITION OF A THREADED PLASTIC RIGID TIP CAP (PRTC) OUTER SHELL.

Current openFDA PMA Record#

Device
OCUCOAT SYRINGE PRODUCT
Applicant
Bausch & Lomb, Inc.
PMA number
P860047
Supplement
S025
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2012-02-03
Decision code
APPR
Date received
2010-11-18
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR AN ALTERNATE ELASTOMERIC TIP CAP MATERIAL (FM27) AND THE ADDITION OF A THREADED PLASTIC RIGID TIP CAP (PRTC) OUTER SHELL.