BRAVA CRT-D, BRAVA QUAD CRT-D, CONCERTO II CRT-D, CONSULTA ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA
FDA premarket approval P010031/S456 · decided 2014-08-15
Approval details
- PMA number
- P010031
- Supplement
- S456
- 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 ICD, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA XT CRT-D VIVA
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2014-07-23
- Decision date
- 2014-08-15
- Days to decision
- 23 days
- Decision code
- OK30
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- CHANGE OF A CLEANING CHEMICAL USED IN THE MANUFACTURE OF THE FLEX CIRCUIT COMPONENT USED IN THE DEVICES.
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