CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT
FDA premarket approval P010031/S307 · decided 2012-06-11
Approval details
- PMA number
- P010031
- Supplement
- S307
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-05-17
- Decision date
- 2012-06-11
- Days to decision
- 25 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE TO THE CONNECTOR CONTACT ASSEMBLY PULL TEST SAMPLE CONFIGURATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.