PMA P910077S141
- Device
- VENTAK PRX, VENTAK MINI FAMILIES OF ICDS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S141
- Product code
- LWS
- Decision date
- 2014-05-02
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
Current openFDA PMA Record#
- Device
- VENTAK PRX, VENTAK MINI FAMILIES OF ICDS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S141
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2014-05-02
- Decision code
- APPR
- Date received
- 2014-02-21
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.