SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
FDA premarket approval P950001 · decided 1996-05-08
Approval details
- PMA number
- P950001
- Trade name
- SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Applicant
- Boston Scientific
- Date received
- 1995-01-13
- Decision date
- 1996-05-08
- Days to decision
- 481 days
- Decision code
- APPR
- Product code
- NVN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 AND 4285
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