PMA P990071S066
- Device
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S066
- Product code
- LPB
- Decision date
- 2025-03-28
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- a reduction in sampling frequency for Limulus Amebocyte Lysate (LAL) testing
Current openFDA PMA Record#
- Device
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S066
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2025-03-28
- Decision code
- OK30
- Date received
- 2025-02-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a reduction in sampling frequency for Limulus Amebocyte Lysate (LAL) testing