PMA P950039S028

Device
THINPREP SLIDES
Applicant
Hologic, Inc.
PMA number
P950039
Supplement
S028
Product code
MKQ
Decision date
2014-04-24
Classification
Processor, Cervical Cytology Slide, Automated
Generic name
Processor, cervical cytology slide, automated
Approval order statement
ADDITION OF A NEW RAW MATERIAL SUPPLIER FOR FLOAT GLASS USED TO MANUFACTURE THE THINPREP PAP TEST MICROSCOPE SLIDE.

Current openFDA PMA Record#

Device
THINPREP SLIDES
Applicant
Hologic, Inc.
PMA number
P950039
Supplement
S028
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2014-04-24
Decision code
OK30
Date received
2014-04-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW RAW MATERIAL SUPPLIER FOR FLOAT GLASS USED TO MANUFACTURE THE THINPREP PAP TEST MICROSCOPE SLIDE.