MEDTRONIC SPRINT FIDELIS LEAD
FDA premarket approval P920015/S037 · decided 2007-07-03
Approval details
- PMA number
- P920015
- Supplement
- S037
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC SPRINT FIDELIS LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2007-05-15
- Decision date
- 2007-07-03
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR DESIGN AND MANUFACTURING CHANGES TO IMPROVE THE DF-1 LEG STRENGTH AND HANDLING CHARACTERISTICS OF SPRINT FIDELIS LEADS.
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