EPIC HF FAMILY CRT-DS
FDA premarket approval P030054/S122 · decided 2009-05-07
Approval details
- PMA number
- P030054
- Supplement
- S122
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- EPIC HF FAMILY CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2009-04-02
- Decision date
- 2009-05-07
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR:1) REPLACING THE EXISTING HAND SOLDER INTERCONNECTIONS BETWEEN SUBASSEMBLIES WITHPLUG/RECEPTACLE CONNECTORS, EPOXY, DIRECT SOLDER OR LASER WELDING.2) USING AN ORGANIC SUBSTRATE FOR THE HYBRID MODULE.3) RECONFIGURING DISCRETE SURFACE MOUNT MAGNETIC COMPONENTS (E.G. HV CONVERTER BOARDASSEMBLY, SENSOR SUPPORT ASSEMBLY) TO INTEGRATE THEM INTO THE HYBRID.
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