PMA P910077S009
- Device
- VENTAK(R) PRX(R) AICD(TM) SYSTEM FOR PECTORAL REPLACEMENT OF VENTAK PRXIII PULE GENERATOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S009
- Product code
- LWS
- Decision date
- 1996-03-14
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR SUBPECTORAL IMPLANTATION OF THE VENTAK PRX III PULSE GENERATOR
Current openFDA PMA Record#
- Device
- VENTAK(R) PRX(R) AICD(TM) SYSTEM FOR PECTORAL REPLACEMENT OF VENTAK PRXIII PULE GENERATOR
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S009
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1996-03-14
- Decision code
- APPR
- Date received
- 1995-06-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SUBPECTORAL IMPLANTATION OF THE VENTAK PRX III PULSE GENERATOR