PMA P010012S016
- Device
- CONTAK RENEWAL AND CONTAK RENEWAL 3
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S016
- Product code
- NIK
- Decision date
- 2003-10-24
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE SYSTEM GUIDE AND TECHNICAL MANUALS FOR THE CONTAK RENEWAL AND CONTAK RENEWAL 3 SYSTEMS.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL AND CONTAK RENEWAL 3
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S016
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2003-10-24
- Decision code
- APPR
- Date received
- 2003-10-06
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR LABELING CHANGES TO THE SYSTEM GUIDE AND TECHNICAL MANUALS FOR THE CONTAK RENEWAL AND CONTAK RENEWAL 3 SYSTEMS.