- Device
- VENTAK(R) P MODEL 1600
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S012
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1996-11-12
- Decision code
- APPR
- Date received
- 1996-10-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT REVIEWED UNDER THE SUPPLEMENT PILOT PROGRAM - THIS APPROVAL APPLIES ONLY TO THE NEW STERILIZATION SITE REQUEST