LYRA IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR:ANGEPASS DEFIBRILLATION LEAD SYSTEM
FDA premarket approval P970024/S001 · decided 1999-03-05
Approval details
- PMA number
- P970024
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LYRA IMPLANTABLE CARDIOVERTER/DEFIBRILLATOR:ANGEPASS DEFIBRILLATION LEAD SYSTEM
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 1998-11-10
- Decision date
- 1999-03-05
- Days to decision
- 115 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for the Lyra(TM) ICD System (Models 2020, 2021, and 2022), Model 6200 Programmer Software, Smart Wand Programming Head Model 3009, Angepass(TM) RV Defibrillation Lead System (Model 4040, 4041, and 4042), and AngePass(TM) SVC Defibrillation Lead System (Models 4080, 4081, and 4082). The devices as modified will be marketed under the trade names Lyra(TM) and AngePass(TM), and are indicated for use in patients who are at risk of sudden death due to ventricular arrhythmias and have experien
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