MAXIMO II DF-4, MAXIMO II, DF-4, PROTECTA DF-4, PROTECTA ICD, PROTECTA XT DF-4, PROTECTA XT ICD, SECURA DF-4, SECURA IC
FDA premarket approval P010031/S317 · decided 2012-08-01
Approval details
- PMA number
- P010031
- Supplement
- S317
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MAXIMO II DF-4, MAXIMO II, DF-4, PROTECTA DF-4, PROTECTA ICD, PROTECTA XT DF-4, PROTECTA XT ICD, SECURA DF-4, SECURA IC
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2012-07-03
- Decision date
- 2012-08-01
- Days to decision
- 29 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGES TO THE RADIO FREQUENCY DEVICE TEST APPLICATION.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.