- Device
- Smartablate System Interface Cable
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S060
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2024-11-15
- Decision code
- APPR
- Date received
- 2024-03-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternate manufacturing site located in Tijuana, Baja California, Mexico (Establishment Registration Number 3008093809) for the TX eco EXT Cable, nMARQ Catheter Interface Cable, and the SmartAblate System Interface Cable