EPIC HF FAMILY CRT-DS
FDA premarket approval P030054/S042 · decided 2006-11-16
Approval details
- PMA number
- P030054
- Supplement
- S042
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPIC HF FAMILY CRT-DS
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2006-10-18
- Decision date
- 2006-11-16
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- USE OF AN AUTOMATED SOLDERING PROCESS TO JOIN THE HV CAPACITOR WIRES TO THE HIGH VOLTAGE PRINTED CIRCUIT BOARD ASSEMBLY CONNECTOR PADS, AS AN ALTERNATE TO THE EXISTING MANUAL SOLDERING PROCESS.
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