MODEL 6943 AND 6945
FDA premarket approval P920015/S013 · decided 1997-09-10
Approval details
- PMA number
- P920015
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 6943 AND 6945
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 1997-07-21
- Decision date
- 1997-09-10
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- Approval for Medtronic(R) Sprint(TM) Models 6943 and 6945 leads.
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