DURATA SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS
FDA premarket approval P950022/S075 · decided 2010-12-06
Approval details
- PMA number
- P950022
- Supplement
- S075
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DURATA SJ4/DF4 FAMILIES OF HIGH VOLTAGE LEADS
- Generic name
- Permanent defibrillator electrodes
- Applicant
- ABBOTT MEDICAL
- Date received
- 2010-10-21
- Decision date
- 2010-12-06
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- NVY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- APPROVAL FOR CHANGES TO THE MOLDED CONNECTOR SUBASSEMBLY FOR IMPROVED MANUFACTURABILITY AND REDUCED COST FOR THE DURATA SJ4 AND DF4 HIGH VOLTAGE LEADS. CHANGES INCLUDE MINOR DESIGN, MATERIAL, AND MANUFACTURING PROCESS CHANGES. ADDITIONALLY, THE CURRENT APPROVED SUPPLIER, ACCELLENT, WILL BE PERFORMING ALL MANUFACTURING OPERATIONS RELATED TO THE MOLDED CONNECTOR SUBASSEMBLY.
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