- Device
- PATH VYSION HER-2 DNA PROBE KIT ASSAY
- Applicant
- Abbott Molecular, Inc.
- PMA number
- P980024
- Supplement
- S008
- Product code
- MVD
- Generic name
- SYSTEM, TEST, HER-2/NEU, NUCLEIC ACID OR SERUM
- Decision date
- 2012-07-17
- Decision code
- APPR
- Date received
- 2012-06-21
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO PATHVYSION LABELING IN ORDER TO PROVIDE CUSTOMERS WITH CONSISTENT, CURRENT, AND CLEAR INFORMATION.