PMA P910077S010
- Device
- VENTAK(R) PRX (TM) II AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S010
- Product code
- LWS
- Decision date
- 1996-02-05
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR AICD MODELS:1705, PRX II MODEL 1715, AND PRX III MODELS 1720/1725, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE
Current openFDA PMA Record#
- Device
- VENTAK(R) PRX (TM) II AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S010
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1996-02-05
- Decision code
- APPR
- Date received
- 1995-06-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REPLACING THE CURRENT CONNECTOR TOP MATERIAL FOR AICD MODELS:1705, PRX II MODEL 1715, AND PRX III MODELS 1720/1725, PELLETHANE 2363-75D POLYURETHANE, WITH TECOTHANE TT1075D-M POLYURETHANE