ST.JUDE MEDICAL RIATA DEFIBRILLATION LEADS
FDA premarket approval P950022/S017 · decided 2003-07-01
Approval details
- PMA number
- P950022
- Supplement
- S017
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST.JUDE MEDICAL RIATA DEFIBRILLATION LEADS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2003-06-09
- Decision date
- 2003-07-01
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE ADDITION OF A FLUOROSCOPIC MARKER IN THE HELIX TIP AND THE ADDITION OF NEW LEAD LENGTHS AND MINOR MODIFICATIONS TO THE SUTURE SLEEVE. THE LEADS ARE INDICATED FOR PERMANENT SENSING AND PACING IN EITHER THE ATRIUM OR THE VENTRICLE, IN COMBINATION WITH A COMPATIBLE PULSE GENERATOR.
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