LYRA(TM) ICD SYSTEMS
FDA premarket approval P970024/S004 · decided 2001-02-06
Approval details
- PMA number
- P970024
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- LYRA(TM) ICD SYSTEMS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2000-11-30
- Decision date
- 2001-02-06
- Days to decision
- 68 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- APPROVAL FOR THE FIRMWARE MODIFICATIONS IN THE LYRA(TM) ICD SYSTEMS.
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