- Device
- VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S056
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2006-05-01
- Decision code
- APPR
- Date received
- 2005-11-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN UPDATE THE VISUAL INSPECTION CRITERIA IN GMAI (GENERAL MANUFACTURING AREA INSTRUCTION) I00093.