PMA P150012S074
- Device
- Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S074
- Product code
- LWP
- Decision date
- 2019-04-08
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.
Current openFDA PMA Record#
- Device
- Accessory Stylet STR 0.013 45CM, Accessory Stylet STR 0.013 52CM,Accessory Stylet STR 0.013 59CM, Accessory Stylet LTPR
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S074
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-04-08
- Decision code
- OK30
- Date received
- 2019-03-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to the frequency, equipment and method for monitoring airborne particulates.