E P TECH EPT-1000 CARDIAC ABLATION SYSTEM
FDA premarket approval P920047/S004 · decided 1995-08-14
Approval details
- PMA number
- P920047
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- E P TECH EPT-1000 CARDIAC ABLATION SYSTEM
- Generic name
- Cardiac ablation percutaneous catheter
- Applicant
- Boston Scientific Corp
- Date received
- 1995-01-12
- Decision date
- 1995-08-14
- Days to decision
- 214 days
- Decision code
- APPR
- Product code
- LPB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- RELOCATION OF ONE OF THE CONTRACT MANUFACTURERS (SEAMED CORPORATION) WHO MANUFACTURERS THE EPT-1000 RF GENERATOR
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