PMA P010012S105
- Device
- RENEWAL FAMILY OF CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S105
- Product code
- LWP
- Decision date
- 2006-03-14
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE FROM A MANUAL TO AN AUTOMATED VISUAL INSPECTION OF DIGITAL DIES.
Current openFDA PMA Record#
- Device
- RENEWAL FAMILY OF CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S105
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-03-14
- Decision code
- OK30
- Date received
- 2006-02-23
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE FROM A MANUAL TO AN AUTOMATED VISUAL INSPECTION OF DIGITAL DIES.