SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD
FDA premarket approval P980049/S008 · decided 2003-02-14
Approval details
- PMA number
- P980049
- Supplement
- S008
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SWIFT(TM) 1CT SERIES 4040 DEFIBRILLATION LEAD
- Generic name
- DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2002-04-15
- Decision date
- 2003-02-14
- Days to decision
- 305 days
- Decision code
- APPR
- Product code
- MRM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR A DEFIBRILLATION LEAD PREVIOUSLY APPROVED FOR MANUFACTURE BY ANGEION UNDER THE TRADE NAME ANGEPASS. THE LEAD IS NOW BEING MANUFACTURED BY ELA MEDICAL, S.A. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SWIFT 1CT 4040 SERIES LEAD AND IS INDICATED FOR USE WITH AN ELA MEDICAL ICD IN PATIENTS WHO ARE AT RISK OF SUDDEN DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND HAVE EXPERIENCED ONE OF THE FOLLOWING SITUATIONS: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFEST
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.