TactiSys Quartz Equipment
FDA premarket approval P130026/S083 · decided 2023-04-17
Approval details
- PMA number
- P130026
- Supplement
- S083
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TactiSys Quartz Equipment
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- St Jude Medical
- Date received
- 2023-01-17
- Decision date
- 2023-04-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for adding a second source supplier, Sigmatron, of the Interface Printed Circuit Board Assembly used in the TactiSys Quartz Equipment to improve supply chain versatility.
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