|
Device | ThinPrep Processors and ThinPrep Imaging System |
Generic Name | Processor, cervical cytology slide, automated |
Applicant | HOLOGIC, INC. 250 Campus Drive Marlborough, MA 01752 |
PMA Number | P950039 |
Supplement Number | S039 |
Date Received | 04/15/2020 |
Decision Date | 08/12/2020 |
Product Code |
MKQ |
Advisory Committee |
Pathology |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of an alternate supplier for the membrane material for the ThinPrep Pap Test Filter used in the ThinPrep processors. |