Amplia MRI CRTD, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRTD, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MR
FDA premarket approval P010031/S693 · decided 2020-04-02
Approval details
- PMA number
- P010031
- Supplement
- S693
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI CRTD, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRTD, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MR
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2020-03-09
- Decision date
- 2020-04-02
- Days to decision
- 24 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Implement a new inspection method for select manufacturing parts.
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