PMA P780007S054

Device
BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES
Applicant
CooperVision, Inc.
PMA number
P780007
Supplement
S054
Product code
LPM
Decision date
2015-07-28
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
ADDITION OF A NEW AUTOCLAVE AT YOUR PUERTO RICO MANUFACTURING FACILITY.

Current openFDA PMA Record#

Device
BIOMEDICS 38 (POLYMACON) SOFT (HYDROPHILIC) EXTENDED-WEAR CONTACT LENSES
Applicant
CooperVision, Inc.
PMA number
P780007
Supplement
S054
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2015-07-28
Decision code
OK30
Date received
2015-07-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW AUTOCLAVE AT YOUR PUERTO RICO MANUFACTURING FACILITY.