PMA P980006S029

Device
PureVision (balafilcon A) Contact Lens
Applicant
Bausch & Lomb, Inc.
PMA number
P980006
Supplement
S029
Product code
LPM
Decision date
2019-10-10
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Approval to remove the prismatic error test method and acceptance criteria from the finished product specifications.

Current openFDA PMA Record#

Device
PureVision (balafilcon A) Contact Lens
Applicant
Bausch & Lomb, Inc.
PMA number
P980006
Supplement
S029
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2019-10-10
Decision code
APPR
Date received
2019-07-15
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to remove the prismatic error test method and acceptance criteria from the finished product specifications.