PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM

FDA premarket approval P950039/S009 · decided 2003-02-05

Approval details

PMA number

P950039

Supplement

S009

Supplement type

Special (Immediate Track)

Supplement reason

Labeling Change - Indications/instructions/shelf life/tradename

Trade name

PRESERVCYT SOLUTION ALTERNATIVE TRANSPORT MEDIUM

Generic name

Processor, cervical cytology slide, automated

Applicant

Hologic, Inc.

Date received

2003-01-21

Decision date

2003-02-05

Days to decision

15 days

Decision code

APPR

Product code

MKQ

Advisory committee

Pathology

Expedited review

No

Location

Malborough, MA

Statement

APPROVAL FOR THE FOLLOWING CHANGES TO THE PACKAGE INSERT: 1) THE ADDITION OF A CONTRAINDICATION FOR THOSE SAMPLES PROCESSED USING THE THINPREP 3000 PROCESSING SYSTEM. 2) THE ADDITION OF A PRECAUTION TO ADDRESS THE ALTERNATIVE SPECIMEN PROCESSING METHODS USING THE THINPREP 2000 PROCESSING SYSTEM FOR THOSE SAMPLES THAT WILL BE TESTED FOR CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE USING THE ROCHE DIAGNOSTICS COBAS AMPLICOR CT/NG TEST. 3) THE ADDITION OF THE ALTERNATIVE SPECIMEN HANDLING METHOD

510(k) clearances by this applicant