PMA P910077S053
- Device
- VENTAK PRX/MINI ICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S053
- Product code
- LWS
- Decision date
- 2007-08-06
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.
Current openFDA PMA Record#
- Device
- VENTAK PRX/MINI ICD SYSTEM
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S053
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2007-08-06
- Decision code
- APPR
- Date received
- 2005-10-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN UPDATE TO THE VISUAL INSPECTION CRITERIA FOR TANTALUM AND CERAMIC CAPACITORS.