CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT
FDA premarket approval P010031/S279 · decided 2011-11-30
Approval details
- PMA number
- P010031
- Supplement
- S279
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONCERTO II/CONSULTA/MAXIMO II/PROTECTA/PROTECTA XT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2011-11-04
- Decision date
- 2011-11-30
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- REMOVAL OF REJECTION CRITERIA AND ASSOCIATED RE-CLEAN PROCESS FOR FLUX BLEED-OUT ON RF MODULES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.