Consulta, Protecta and Protecta XT CRT-D
FDA premarket approval P010031/S678 · decided 2019-08-30
Approval details
- PMA number
- P010031
- Supplement
- S678
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Consulta, Protecta and Protecta XT CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-08-01
- Decision date
- 2019-08-30
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Automated tester equipment conversion from LTX to SPEA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.