QuickFlex u and Quartet leads
FDA premarket approval P030054/S323 · decided 2018-04-02
Approval details
- PMA number
- P030054
- Supplement
- S323
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- QuickFlex u and Quartet leads
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Applicant
- ABBOTT MEDICAL
- Date received
- 2017-02-17
- Decision date
- 2018-04-02
- Days to decision
- 409 days
- Decision code
- APPR
- Product code
- NIK
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for an alternate supplier for material used for lead insulation tubing.
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