Amplia MRI CRT-D, MRI Quad CRT-D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, MRI Quad CRT-D; Compia MRI CRT-D, MRI Quad
FDA premarket approval P010031/S659 · decided 2019-03-26
Approval details
- PMA number
- P010031
- Supplement
- S659
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Amplia MRI CRT-D, MRI Quad CRT-D; Brava CRT-D, Quad CRT-D; Claria MRI CRT-D, MRI Quad CRT-D; Compia MRI CRT-D, MRI Quad
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2019-02-25
- Decision date
- 2019-03-26
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- New external supplier for the dimer diamine for the Dadet epoxy.
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