PMA P150012S030
- Device
- Ingevity Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S030
- Product code
- LWP
- Decision date
- 2017-05-23
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Changes to the quality control analytical test methods used to evaluate dexamethasone acetate for passive fixation distal tip subassembly test articles.
Current openFDA PMA Record#
- Device
- Ingevity Lead
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S030
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-05-23
- Decision code
- OK30
- Date received
- 2017-04-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Changes to the quality control analytical test methods used to evaluate dexamethasone acetate for passive fixation distal tip subassembly test articles.