PMA P010012S132
- Device
- CONTRAK RENEWAL 3
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S132
- Product code
- LWP
- Decision date
- 2006-06-22
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL TO ADD WARNING REGARDING CORRECT DEVICE IMPLANT ORIENTATION.
Current openFDA PMA Record#
- Device
- CONTRAK RENEWAL 3
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S132
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-06-22
- Decision code
- APPR
- Date received
- 2006-05-23
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD WARNING REGARDING CORRECT DEVICE IMPLANT ORIENTATION.