SAFIRE BLU DUO ABLATION CATHETERS
FDA premarket approval P110016/S005 · decided 2012-11-29
Approval details
- PMA number
- P110016
- Supplement
- S005
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SAFIRE BLU DUO ABLATION CATHETERS
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Applicant
- ABBOTT MEDICAL
- Date received
- 2012-07-11
- Decision date
- 2012-11-29
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- OAD
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR AN ALTERNATE SUPPLIER OF THE CATHETER SHAFT SUBASSEMBLY.
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