TactiCath Quartz Set
FDA premarket approval P130026/S028 · decided 2018-03-26
Approval details
- PMA number
- P130026
- Supplement
- S028
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TactiCath Quartz Set
- Generic name
- Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
- Applicant
- St Jude Medical
- Date received
- 2017-12-15
- Decision date
- 2018-03-26
- Days to decision
- 101 days
- Decision code
- APPR
- Product code
- OAE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St. Paul, MN
- Statement
- Approval for changes to receiving inspection and manufacturing procedures for tests related to the FISO module and force testing.
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