PMA P860047S028

Device
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Applicant
Bausch & Lomb, Inc.
PMA number
P860047
Supplement
S028
Product code
LZP
Decision date
2014-03-28
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
USE OF A NEW POUCH SEALER FOR THE PACKAGING PROCESS OF OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE.

Current openFDA PMA Record#

Device
OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE (OVD)
Applicant
Bausch & Lomb, Inc.
PMA number
P860047
Supplement
S028
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2014-03-28
Decision code
OK30
Date received
2014-03-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF A NEW POUCH SEALER FOR THE PACKAGING PROCESS OF OCUCOAT OPHTHALMIC VISCOSURGICAL DEVICE.