- Device
- CONTACK RENEWAL IS1/DR1 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S081
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (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.