THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER
FDA premarket approval P110016/S017 · decided 2015-05-20
Approval details
- PMA number
- P110016
- Supplement
- S017
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- THERAPY COOL PATH DUO ABLATION CATHETER AND THERAPY COOL FLEX ABLATION CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2015-04-20
- Decision date
- 2015-05-20
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- CHANGE IN MANUFACTURING ROOM LOCATION OF THE BAND ELECTRODE SUB-ASSEMBLY.
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