PMA P840068S049
- Device
- DELTA/VISTA FAMILIES
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S049
- Product code
- LWP
- Decision date
- 2011-04-29
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- DELTA/VISTA FAMILIES
- Applicant
- Boston Scientific
- PMA number
- P840068
- Supplement
- S049
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2011-04-29
- Decision code
- OK30
- Date received
- 2011-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN BIOLOGICAL INDICATOR MODEL USED AS PART OF THE MANUFACTURING PROCESS.