JEWEL AF SYSTEM
FDA premarket approval P980050/S001 · decided 2001-04-06
Approval details
- PMA number
- P980050
- Supplement
- S001
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- JEWEL AF SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2000-06-15
- Decision date
- 2001-04-06
- Days to decision
- 295 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- APPROVAL FOR THE MEDTRONIC(R) MODEL 7250 JEWEL(R) AF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM, MEDTRONIC MODEL 9465 INCHECK(TM) PATIENTS ASSISTANT AND THE MEDTRONIC TRANSVENE(R) CS/SVC MODEL 6937A LEAD. THE SYSTEM IS INTENDED TO PROVIDE PACING, CARDIOVERSION AND DEFIBRILLATION FOR TREATMENT OF PATIENTS WITH SYMPTOMATIC DRUG REFRACTORY ATRIAL FIBRILLATION AND/OR LIFE-THREATENING VENTRICULAR TACHYARRHYTHMIAS.
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