PMA P990071S006
- Device
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S006
- Product code
- DRF
- Decision date
- 2005-03-21
- Classification
- Catheter, Electrode Recording, Or Probe, Electrode Recording
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Approval order statement
- APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTIONS FOR USE.
Current openFDA PMA Record#
- Device
- STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S006
- Product code
- DRF
- Generic name
- CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
- Decision date
- 2005-03-21
- Decision code
- APPR
- Date received
- 2005-02-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES THAT STRENGTHEN THE INSTRUCTIONS FOR USE.