Amplia MRI CRTD DTMB1D4, DTMB1D1; Amplia MRI Quad CRT-D DTMB1QQ, DTMB1Q1; Brava CRT-D DTBC1D4, DTBC1D1, Brava Quad CRTD
FDA premarket approval P010031/S578 · decided 2017-02-21
Approval details
- PMA number
- P010031
- Supplement
- S578
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI CRTD DTMB1D4, DTMB1D1; Amplia MRI Quad CRT-D DTMB1QQ, DTMB1Q1; Brava CRT-D DTBC1D4, DTBC1D1, Brava Quad CRTD
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2017-01-25
- Decision date
- 2017-02-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Additional wirebond equipment for use in hybrid manufacturing at Medtronic Tempe Campus.
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