PMA P910077S088
- Device
- VENTAK MINI
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S088
- Product code
- LWS
- Decision date
- 2008-07-02
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.
Current openFDA PMA Record#
- Device
- VENTAK MINI
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S088
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2008-07-02
- Decision code
- OK30
- Date received
- 2008-06-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF CERTAIN ELECTRICAL TESTING FOR CAPACITORS DURING INCOMING INSPECTION ACTIVITIES.