PMA P970018S020

Device
BD PREPSTAIN SYSTEM
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S020
Product code
MKQ
Decision date
2010-03-08
Generic name
Processor, cervical cytology slide, automated
Approval order statement
REPLACE THE OFF-THE-SHELF VACUUM PUMP WITH AN ALTERNATE MODEL TO COMPENSATE FOR A CHANGE IN THE SUPPLIER.

Current openFDA PMA Record#

Device
BD PREPSTAIN SYSTEM
Applicant
Bd Diagnostic Systems
PMA number
P970018
Supplement
S020
Product code
MKQ
Generic name
Processor, cervical cytology slide, automated
Decision date
2010-03-08
Decision code
OK30
Date received
2010-02-18
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
REPLACE THE OFF-THE-SHELF VACUUM PUMP WITH AN ALTERNATE MODEL TO COMPENSATE FOR A CHANGE IN THE SUPPLIER.