MODEL 6948 AND 6930 LEADS
FDA premarket approval P920015/S030 · decided 2004-06-08
Approval details
- PMA number
- P920015
- Supplement
- S030
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MODEL 6948 AND 6930 LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2003-12-22
- Decision date
- 2004-06-08
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE ADDITION OF A POLYURETHANE OVERLAY.
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