PMA P010012S061
- Device
- CONTAK RENEWAL 3&4 FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S061
- Product code
- LWP
- Decision date
- 2005-09-21
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADDITION OF AN AUTOMATED VISION SYSTEM (EQUIPMENT) TO THE INSPECTION PROCESS FOR INSPECTION OF HEADERS THAT WILL REPLACE THE MANUAL VISUAL INSPECTION PROCESS TO THE FAMILY OF CRT AND ICD DEVICES.
Current openFDA PMA Record#
- Device
- CONTAK RENEWAL 3&4 FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S061
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2005-09-21
- Decision code
- OK30
- Date received
- 2005-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN AUTOMATED VISION SYSTEM (EQUIPMENT) TO THE INSPECTION PROCESS FOR INSPECTION OF HEADERS THAT WILL REPLACE THE MANUAL VISUAL INSPECTION PROCESS TO THE FAMILY OF CRT AND ICD DEVICES.