CONCERTO II/CONSULTA/MAXIMO II
FDA premarket approval P010031/S264 · decided 2011-08-04
Approval details
- PMA number
- P010031
- Supplement
- S264
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II/CONSULTA/MAXIMO II
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-07-06
- Decision date
- 2011-08-04
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MANUFACTURING PROCESS CHANGE FOR THE DETERMINATION OF WORST CASE DEVICE REPRESENTATIVE FOR ETHYLENE OXIDE (EO) RESIDUAL TESTING FOR ETHYLENE OXIDE STERILIZATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.