PMA P010012S099
- Device
- RENEWAL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S099
- Product code
- LWP
- Decision date
- 2006-05-05
- 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 INSPECTION OF THE SOLDER BALLS ON BALL GRID ARRAY MODULES.
Current openFDA PMA Record#
- Device
- RENEWAL
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S099
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2006-05-05
- Decision code
- APPR
- Date received
- 2005-12-21
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE FROM A MANUAL TO AN AUTOMATED INSPECTION OF THE SOLDER BALLS ON BALL GRID ARRAY MODULES.