FLEXABILITY ABLATION CATHETER (BI AND UNI DIRECTIONAL)
FDA premarket approval P110016/S018 · decided 2015-07-09
Approval details
- PMA number
- P110016
- Supplement
- S018
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLEXABILITY ABLATION CATHETER (BI AND UNI DIRECTIONAL)
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-06-29
- Decision date
- 2015-07-09
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A NEW IN-PROCESS INSPECTION STEP.
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