PMA P060017S001
- Device
- GENESEARCH BREAST LYMPH NODE
- Applicant
- Janssen Diagnostics
- PMA number
- P060017
- Supplement
- S001
- Product code
- OCB
- Decision date
- 2007-10-23
- Generic name
- RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
- Approval order statement
- APPROVAL FOR THE POST-APPROVAL STUDY.
Current openFDA PMA Record#
- Device
- GENESEARCH BREAST LYMPH NODE
- Applicant
- Janssen Diagnostics
- PMA number
- P060017
- Supplement
- S001
- Product code
- OCB
- Generic name
- RT-PCR multigene expression test, sentinel lymph node, cancer metastasis detection
- Decision date
- 2007-10-23
- Decision code
- APPR
- Date received
- 2007-08-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL FOR THE POST-APPROVAL STUDY.