PMA P910077S040
- Device
- VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S040
- Product code
- LWS
- Decision date
- 2003-12-17
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR LABELING CHANGES SPECIFIC TO DEFIBRILLATOR IMPLANT TESTING CRITERIA.
Current openFDA PMA Record#
- Device
- VENTAK PRX AND MINI IMPLANTABLE CARDIOVERTER DEFIBRILLATORS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S040
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2003-12-17
- Decision code
- APPR
- Date received
- 2003-07-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR LABELING CHANGES SPECIFIC TO DEFIBRILLATOR IMPLANT TESTING CRITERIA.