EPIC HF & ATLAS + HF CRT-D SYSTEMS
FDA premarket approval P030054/S005 · decided 2005-03-08
Approval details
- PMA number
- P030054
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPIC HF & ATLAS + HF CRT-D SYSTEMS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2005-01-24
- Decision date
- 2005-03-08
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR MODEL 3307 V.4.8.3 AND MODEL 3307 V.4.8.4 PROGRAMMER SOFTWARE.
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