PMA P910071S015

Device
ADATO SIL-OL 5000 SILICONE OIL
Applicant
Bausch & Lomb
PMA number
P910071
Supplement
S015
Product code
LWL
Decision date
2015-08-28
Generic name
Fluid, intraocular
Approval order statement
ADDITION OF A REINFORCING HEAD SEAM TO THE INNER POUCH OF THE DEVICE.

Current openFDA PMA Record#

Device
ADATO SIL-OL 5000 SILICONE OIL
Applicant
Bausch & Lomb
PMA number
P910071
Supplement
S015
Product code
LWL
Generic name
Fluid, intraocular
Decision date
2015-08-28
Decision code
OK30
Date received
2015-08-07
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A REINFORCING HEAD SEAM TO THE INNER POUCH OF THE DEVICE.