PMA P150012S072
- Device
- INGEVITY Distal Tip Laser Weld Process
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S072
- Product code
- LWP
- Decision date
- 2019-03-14
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Modifications of the distal tip laser weld, laser weld fixtures, processes, and software used for the helix to coupler weld.
Current openFDA PMA Record#
- Device
- INGEVITY Distal Tip Laser Weld Process
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S072
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2019-03-14
- Decision code
- OK30
- Date received
- 2019-02-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications of the distal tip laser weld, laser weld fixtures, processes, and software used for the helix to coupler weld.