FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),FLEXABILITY ABLATION CATHETERS (BI-DIRECTIONAL)
FDA premarket approval P110016/S022 · decided 2015-09-14
Approval details
- PMA number
- P110016
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLEXABILITY ABLATION CATHETERS (UNI-DIRECTIONAL),FLEXABILITY ABLATION CATHETERS (BI-DIRECTIONAL)
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-09-01
- Decision date
- 2015-09-14
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- REDUCTION IN BACTERIAL ENDOTOXIN TESTING FREQUENCY FOR THE FLEXABILITY ABLATION CATHETERS MANUFACTURED IN PLYMOUTH, MN.
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