PMA P910077S045
- Device
- VENTAK PRX,VENTAK MINI
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S045
- Product code
- LWS
- Decision date
- 2004-05-14
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.
Current openFDA PMA Record#
- Device
- VENTAK PRX,VENTAK MINI
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S045
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2004-05-14
- Decision code
- OK30
- Date received
- 2004-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE AERATION TIME USED BY GUIDANT'S ALTERNATE STERILIZATION SITE.