PMA P910077S021
- Device
- VENTAK PRX AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S021
- Product code
- LWS
- Decision date
- 1997-08-08
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).
Current openFDA PMA Record#
- Device
- VENTAK PRX AICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S021
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1997-08-08
- Decision code
- APPR
- Date received
- 1997-07-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE MODIFICATIONS TO THE MODEL 2090 MULTIPLE APPLICATION UTILITY (MAU).