ST. JUDE MEDICAL EPIC HF SYSTEM
FDA premarket approval P030054/S155 · decided 2011-02-11
Approval details
- PMA number
- P030054
- Supplement
- S155
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ST. JUDE MEDICAL EPIC HF SYSTEM
- Generic name
- Drug eluting permanent left ventricular (lv) pacemaker electrode
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-06-22
- Decision date
- 2011-02-11
- Days to decision
- 234 days
- Decision code
- APPR
- Product code
- OJX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR A NEW 4.3-4.7 FR SLIT SUTURE SLEEVE ACCESSORY KIT TO BE USED WITH THE APPROVED 1258T QUICKFLEX ¿ LEAD.
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