PMA P990071S002
- Device
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S002
- Product code
- DRF
- Decision date
- 2002-02-15
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- APPROVAL FOR 1) ADAPTER CABLES (MODELS D-1170-27-001, D-1170-28-001, AND D-1170-29-001) THAT CONNECT THE STOCKERT 70 RF GENERATOR CABLE TO COMPATIBLE CATHETERS AND 2) A NEW INDICATIONS FOR USE FOR THE STOCKERT 70 RF GENERATOR. THE ADAPTER CABLES WILL BE MARKETED UNDER THE TRADE NAME STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION. BOTH THE STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION AND STOCKERT 70 RF GENERATOR ARE INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES.
Current openFDA PMA Record#
- Device
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S002
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2002-02-15
- Decision code
- APPR
- Date received
- 2001-11-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR 1) ADAPTER CABLES (MODELS D-1170-27-001, D-1170-28-001, AND D-1170-29-001) THAT CONNECT THE STOCKERT 70 RF GENERATOR CABLE TO COMPATIBLE CATHETERS AND 2) A NEW INDICATIONS FOR USE FOR THE STOCKERT 70 RF GENERATOR. THE ADAPTER CABLES WILL BE MARKETED UNDER THE TRADE NAME STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION. BOTH THE STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION AND STOCKERT 70 RF GENERATOR ARE INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE CATHETER FOR CARDIAC ABLATION PROCEDURES.