BRAVA CRT-D; BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTCA CRT-D & XT CRT-D, VIVA QUAD
FDA premarket approval P010031/S489 · decided 2015-02-27
Approval details
- PMA number
- P010031
- Supplement
- S489
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BRAVA CRT-D; BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA CRT-D, MAXIMO II CRT-D, PROTECTCA CRT-D & XT CRT-D, VIVA QUAD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2015-02-02
- Decision date
- 2015-02-27
- Days to decision
- 25 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MANUFACTURING PROCESS CHANGES FOR XE161 CRYSTAL COMPONENT USED IN THE DEVICES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.