- Device
- VENTAK P AUTOMATIC IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM/ LEAD TUNNELER KIT
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S078
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-03-31
- Decision code
- APPR
- Date received
- 2014-03-04
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD STERILIZATION DETAIL INFORMATION AND TO REMOVE THE CIDEX CLEANING STEP FROM THE INSTRUCTIONS FOR USE.