PMA P950001S004
- Device
- SELUTE(R) PICOTIP(TM) STEROID-ELUTING ENDOCARDIAL ATRIAL-J LEADS
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S004
- Product code
- NVY
- Decision date
- 2000-05-10
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- Approval for the Atrial J SELUTE PICOTIP Steroid Eluting Pacing Lead, Models 4063 and 4064.
Current openFDA PMA Record#
- Device
- SELUTE(R) PICOTIP(TM) STEROID-ELUTING ENDOCARDIAL ATRIAL-J LEADS
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S004
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2000-05-10
- Decision code
- APPR
- Date received
- 1999-11-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Atrial J SELUTE PICOTIP Steroid Eluting Pacing Lead, Models 4063 and 4064.