TactiCath Quartz Contact Force Ablation Catheter
FDA premarket approval P130026/S056 · decided 2020-04-06
Approval details
- PMA number
- P130026
- Supplement
- S056
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TactiCath Quartz Contact Force Ablation Catheter
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- St Jude Medical
- Date received
- 2020-03-10
- Decision date
- 2020-04-06
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Changes to the optical fiber manufacturing process of the TactiCath Quartz contact force ablation catheter.
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