VARIOUS FAMILIES OF CRT-ICD'S
FDA premarket approval P010031/S068 · decided 2007-06-14
Approval details
- PMA number
- P010031
- Supplement
- S068
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VARIOUS FAMILIES OF CRT-ICD'S
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2007-05-21
- Decision date
- 2007-06-14
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE OF THREE COMPONENTS USED IN THE MANUFACTURING O 2490C MEDTRONIC CARELINK MONITOR. THE COMPONENTS BEING CHANGED ARE THE VOLTAGE CONTROLLED OSCILLATOR (VCXO) AND TWO CAPACITORS. THOSE ARE: 1) THE VCXO PROVIDES AN OUTPUT FREQUENCY IN RESPONSE TO A GIVEN VOLTAGE INPUT. FOR THE 2490C MEDTRONIC CARELINK MONITOR THE VCXO SUPPORTS THE TELEMETRY FEATURE OF THE MONITOR. THE SAME MANUFACTURER PROVIDES BOTH THE ORIGINAL PART (PART NUMBER CSX750VCB20.000MUT) AND THE NEW PART (PART NUMBE
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