EPIC HF/ATLAS+HF FAMILY OF CRT-DS
FDA premarket approval P030054/S118 · decided 2009-03-23
Approval details
- PMA number
- P030054
- Supplement
- S118
- Supplement type
- Real-Time Process
- Trade name
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-02-17
- Decision date
- 2009-03-23
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR THE MODIFICATIONS OF THE C64 IC (VERSION P) FOR THE EPIC II / ATLAS II PLATFORM OF ICDS, AND SIO2 IC (VERSION G) FOR THE EPIC+ / ATLAS+ AND EPIC II / ATLAS II PLATFORM OF ICDS.
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