MEDTRONIC SPRINT LEADS
FDA premarket approval P920015/S038 · decided 2008-02-06
Approval details
- PMA number
- P920015
- Supplement
- S038
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MEDTRONIC SPRINT LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2007-09-12
- Decision date
- 2008-02-06
- Days to decision
- 147 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR CHANGING THE MOLDING VENDOR AND MOLDING PROCESS PARAMETERS FOR THE IS-1 CONNECTOR SLEEVE COMPONENT FOR SPRINT LEAD MODELS 6930, 6931, 6945, 6947, 6948, 6949, AND 6944.
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