PMA P990071S067
- Device
- SMARTABLATE™ System Interface Cable (D-1303-02-S)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S067
- Product code
- LPB
- Decision date
- 2025-09-15
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- an alternative subassembly manufacturer for the SMARTABALTE™ System Interface Cable (D-1303-02-S)
Current openFDA PMA Record#
- Device
- SMARTABLATE™ System Interface Cable (D-1303-02-S)
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S067
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2025-09-15
- Decision code
- OK30
- Date received
- 2025-08-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an alternative subassembly manufacturer for the SMARTABALTE™ System Interface Cable (D-1303-02-S)