EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS
FDA premarket approval P030054/S181 · decided 2011-06-21
Approval details
- PMA number
- P030054
- Supplement
- S181
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2011-03-14
- Decision date
- 2011-06-21
- Days to decision
- 99 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR SOFTWARE MODEL MN5000 V.5.0 FOR USE ON THE MERLIN.NET SYSTEM AND MODEL EX2000 V.5.0 FOR USE ON MERLIN@ HOME DEVICES.
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