Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Brava Quad CRT-D DTBC
FDA premarket approval P010031/S548 · decided 2016-05-25
Approval details
- PMA number
- P010031
- Supplement
- S548
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI CRT-D DTMB1D4; Amplia MRI Quad CRT-D DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Brava Quad CRT-D DTBC
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-04-29
- Decision date
- 2016-05-25
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Change to the supplier's cleaning process for the accelerometer.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.