PMA P010012S054
- Device
- CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), MODELS H135, H170, H175, H177, AND H179
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S054
- Product code
- LWP
- Decision date
- 2005-08-04
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE IN TEST SOFTWARE FOR THE CONTAK RENEWAL CRT-DDEVICES PER ROUTINE PROCEDURES.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D), MODELS H135, H170, H175, H177, AND H179
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S054
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2005-08-04
- Decision code
- OK30
- Date received
- 2005-07-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN TEST SOFTWARE FOR THE CONTAK RENEWAL CRT-DDEVICES PER ROUTINE PROCEDURES.