PMA P830060S053
- Device
- VENTAK
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S053
- Product code
- LWS
- Decision date
- 2004-02-10
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.
Current openFDA PMA Record#
- Device
- VENTAK
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S053
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2004-02-10
- Decision code
- OK30
- Date received
- 2004-01-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM THE USE OF BIOLOGICAL INDICATORS AS THE STERILIZATION RELEASE MECHANISM, TO THE USE OF PARAMETRIC RELEASE.