PMA P910077S039
- Device
- VENTAK PRX AND MINI ICDS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S039
- Product code
- LWS
- Decision date
- 2003-03-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR CHANGES TO THE PATIENT HANDBOOKS.
Current openFDA PMA Record#
- Device
- VENTAK PRX AND MINI ICDS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S039
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2003-03-21
- Decision code
- APPR
- Date received
- 2002-12-12
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES TO THE PATIENT HANDBOOKS.