ACCELEROMETER TANTALUM CAPACITOR CHANGE
FDA premarket approval P980016/S066 · decided 2006-03-02
Approval details
- PMA number
- P980016
- Supplement
- S066
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACCELEROMETER TANTALUM CAPACITOR CHANGE
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Date received
- 2006-01-17
- Decision date
- 2006-03-02
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR A CHANGE IN HYBRID COMPONENTS, THE ACCELEROMETER (XE407) AND TANTALUM CAPACITOR (XT122) FOR THE PRODUCTS PREVIOUSLY LISTED.
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