BOND ORACLE HER2 IHC SYSTEM
FDA premarket approval P090015/S001 · decided 2014-02-11
Approval details
- PMA number
- P090015
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BOND ORACLE HER2 IHC SYSTEM
- Generic name
- SYSTEM, TEST, HER-2/NEU, IHC
- Applicant
- Leica Biosystems
- Date received
- 2013-07-26
- Decision date
- 2014-02-11
- Days to decision
- 200 days
- Decision code
- APPR
- Product code
- MVC
- Advisory committee
- Pathology
- Expedited review
- No
- Location
- Danvers, MA
- Statement
- APPROVAL FOR THE MANUFACTURING CHANGES TO THE BOND-MAX SOFTWARE, INSTRUMENT STYLING AND USABILITY, THE REAGENT AND BOND-MAX INSTRUMENT MANUFACTURING PROCESSES, AND ASSOCIATED LABELING CHANGES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.