PMA P920047S020
- Device
- EPT-1000 CARDIAC ABLATION SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S020
- Product code
- LPB
- Decision date
- 2003-11-25
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- ELIMINATION OF A CHEMICAL FROM THE RING CLEANING PROCEDURE AND THE IMPLEMENTATION OF THE NEW AUTOMATED UV CURING FIXTURE.
Current openFDA PMA Record#
- Device
- EPT-1000 CARDIAC ABLATION SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S020
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2003-11-25
- Decision code
- OK30
- Date received
- 2003-10-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF A CHEMICAL FROM THE RING CLEANING PROCEDURE AND THE IMPLEMENTATION OF THE NEW AUTOMATED UV CURING FIXTURE.