PMA P890061S023
- Device
- VENTAK P AICD SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S023
- Product code
- LWS
- Decision date
- 2013-09-25
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.
Current openFDA PMA Record#
- Device
- VENTAK P AICD SYSTEMS
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S023
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2013-09-25
- Decision code
- OK30
- Date received
- 2013-08-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- USE OF NEW TRACEABILITY/TRACKING SOFTWARE IN THE INCOMING RECEIVING INSPECTION AREA.