PMA P020025S007
- Device
- EPT-1000XP CARDIAC ABLATION SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S007
- Product code
- OAD
- Decision date
- 2004-10-12
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- ELIMINATION OF A CLEANING AGENT FROM THE RING CLEANING PROCEDURE AND THE IMPLEMENTATION OF A NEW AUTOMATED UV CURING FIXTURE.
Current openFDA PMA Record#
- Device
- EPT-1000XP CARDIAC ABLATION SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P020025
- Supplement
- S007
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2004-10-12
- Decision code
- OK30
- Date received
- 2004-09-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ELIMINATION OF A CLEANING AGENT FROM THE RING CLEANING PROCEDURE AND THE IMPLEMENTATION OF A NEW AUTOMATED UV CURING FIXTURE.