PMA P010012S094
- Device
- RENEWAL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S094
- Product code
- LWP
- Decision date
- 2006-01-20
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS FOR THE TRANSFORMER COMPONENT.
Current openFDA PMA Record#
- Device
- RENEWAL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S094
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-01-20
- Decision code
- OK30
- Date received
- 2005-12-21
- Supplement type
- 30-Day Notice
- Approval order statement
- CHANGE IN THE MANUFACTURING PROCESS FOR THE TRANSFORMER COMPONENT.