PMA P010012S319
- Device
- ACUITY SPIRAL LEAD
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S319
- Product code
- LWP
- Decision date
- 2013-03-08
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- ACUITY SPIRAL LEAD
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S319
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-03-08
- Decision code
- APPR
- Date received
- 2013-01-09
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.