EPIC HF CRT-D
FDA premarket approval P030054/S003 · decided 2004-10-25
Approval details
- PMA number
- P030054
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPIC HF CRT-D
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2004-09-27
- Decision date
- 2004-10-25
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN OF THE FEEDTHROUGH ASSEMBLY OF THE EPIC HF DEVICE MODEL V-338 AND MINOR MODIFICATIONS TO PROVIDE CONSISTENCY IN THE MANUFACTURING PROCESS OF EPIC HF AND EPIC DR/VR ICDS.
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