PMA P160025S002
- Device
- Astron Pulsar/Pulsar-18 Stent System
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S002
- Product code
- NIP
- Decision date
- 2017-08-07
- Classification
- Stent, Superficial Femoral Artery
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Approval order statement
- Approval for the final PMA PAS Protocol Administrative Addendum (dated June 6, 2017) containing the PAS long-term data analysis plan and for extending the Post-Approval Study (PAS) reporting frequency from 6 months to 12 months.
Current openFDA PMA Record#
- Device
- Astron Pulsar/Pulsar-18 Stent System
- Applicant
- Biotronik AG
- PMA number
- P160025
- Supplement
- S002
- Product code
- NIP
- Generic name
- STENT, SUPERFICIAL FEMORAL ARTERY
- Decision date
- 2017-08-07
- Decision code
- APPR
- Date received
- 2017-06-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval for the final PMA PAS Protocol Administrative Addendum (dated June 6, 2017) containing the PAS long-term data analysis plan and for extending the Post-Approval Study (PAS) reporting frequency from 6 months to 12 months.