- Device
- VENTAK(R) P MODEL 1600
- Applicant
- Boston Scientific
- PMA number
- P890061
- Supplement
- S010
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1995-11-20
- Decision code
- APPR
- Date received
- 1995-04-06
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR ALTERNATE MANUFACTURING SITE FOR ASSEMBLY OF THE EXTERNAL PRODUCTS (PROGRAMMERS, SOFTWARE MODULES/DISKS, EXTERNAL COARDIOVERTER DEFIBRILLATORS, AND RELATED ACCESSORIES) WHICH ARE USED WITH CPI PACEMAKER AND AICD SYSTEMS. THE PROPOSED ALTERNATE MANUFACTURING SITE (CARDIGAN FACILITY) IS LOCATED AT THE FOLLOWING ADDRESS: CPI CARDIAGAN FACILITY, 599 CARDIGAN ROAD, SHOREVIEW, MINNESOTA 55126