PMA P920047S004
- Device
- E P TECH EPT-1000 CARDIAC ABLATION SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S004
- Product code
- LPB
- Decision date
- 1995-08-14
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- RELOCATION OF ONE OF THE CONTRACT MANUFACTURERS (SEAMED CORPORATION) WHO MANUFACTURERS THE EPT-1000 RF GENERATOR
Current openFDA PMA Record#
- Device
- E P TECH EPT-1000 CARDIAC ABLATION SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P920047
- Supplement
- S004
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 1995-08-14
- Decision code
- APPR
- Date received
- 1995-01-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- RELOCATION OF ONE OF THE CONTRACT MANUFACTURERS (SEAMED CORPORATION) WHO MANUFACTURERS THE EPT-1000 RF GENERATOR