LIVEWIRE TC CARDIAC ABLATION CATHETER
FDA premarket approval P960016/S003 · decided 1999-12-13
Approval details
- PMA number
- P960016
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LIVEWIRE TC CARDIAC ABLATION CATHETER
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- St Jude Medical
- Date received
- 1999-06-28
- Decision date
- 1999-12-13
- Days to decision
- 168 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- Approval for a change in sterilization process from 12% EtO/88% CFC to 100% EtO (while at the same time transferring the sterilization to an outside contract sterilization facility).
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| Pacel Flow Directed Pacing Catheter (K161873) | St Jude Medical | 2016-11-22 |