Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Concerto II CRT-D D274TRK; Consulta CRT-D D204TRM, D224
FDA premarket approval P010031/S531 · decided 2016-02-29
Approval details
- PMA number
- P010031
- Supplement
- S531
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Brava CRT-D DTBC1D4, DTBC1D1; Brava Quad CRT-D DTBC1Q1, DTBC1QQ; Concerto II CRT-D D274TRK; Consulta CRT-D D204TRM, D224
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2016-02-05
- Decision date
- 2016-02-29
- Days to decision
- 24 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Modify the hybrid ionic contamination limit.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.