MEDTRONIC SPRINT FIDELIS LEADS MODELS,6949,6948,6931,6930
FDA premarket approval P920015/S032 · decided 2005-12-01
Approval details
- PMA number
- P920015
- Supplement
- S032
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC SPRINT FIDELIS LEADS MODELS,6949,6948,6931,6930
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2005-09-02
- Decision date
- 2005-12-01
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL TO CHANGE THE AERATION TIME FOLLOWING STERILIZATION OF THE SPRINT FIDELIS LEADS.
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