Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRTD DTBC1Q1, DTBC1QQ; Concerto II CRTD, D274TRK; Consulta CRT-D D204TRM, D224T
FDA premarket approval P010031/S529 · decided 2016-02-29
Approval details
- PMA number
- P010031
- Supplement
- S529
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRTD DTBC1Q1, DTBC1QQ; Concerto II CRTD, D274TRK; Consulta CRT-D D204TRM, D224T
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-02-03
- Decision date
- 2016-02-29
- Days to decision
- 26 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- New supplier of ceramic capacitors.
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