PMA P150012S006
- Device
- ACUITY X4 LEAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S006
- Product code
- LWP
- Decision date
- 2016-07-13
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.
Current openFDA PMA Record#
- Device
- ACUITY X4 LEAD
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S006
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2016-07-13
- Decision code
- APPR
- Date received
- 2016-05-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for the removal of redundant specifications and testing associated with batch release and drug stability testing.