THERAPY COOL PATH DUO ABLATION CATHETER
FDA premarket approval P110016/S004 · decided 2012-09-07
Approval details
- PMA number
- P110016
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAPY COOL PATH DUO ABLATION CATHETER
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-07-10
- Decision date
- 2012-09-07
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A DESIGN MODIFICATION TO THE BOND BETWEEN THAT CATHETER SHAFT AND THE EXTENSION TUBING. SPECIFICALLY, YOU PROPOSE TO CHANGE THE ADHESIVE FROM LOCTITE TO URETHANE AND TO MODIFY THE CONTACT HOLE FROM A CIRCULAR TO AN OCTAGONAL SHAPE.
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