MEDTRONIC(R) MODEL 6934S TRANSVENE RV LEAD
FDA premarket approval P920015/S007 · decided 1996-03-13
Approval details
- PMA number
- P920015
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MEDTRONIC(R) MODEL 6934S TRANSVENE RV LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 1995-08-07
- Decision date
- 1996-03-13
- Days to decision
- 219 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FORTHE MEDTRONIC MODEL 6934S TRANSVENE RIGHT VENTRICULAR LEAD
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