SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
FDA premarket approval P950001/S001 · decided 1996-11-12
Approval details
- PMA number
- P950001
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 1996-10-16
- Decision date
- 1996-11-12
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ALTERNATE STERILIZATION FACILITY LOCATED AT COSMED OF ILLINOIS, 1160 NORTHPOINT BLVD., WAUKEGAN, IL 60085 - THIS SUPPLEMENT REVIEWED UNDER THE PILOT PROGRAM AND THE APPROVAL ONLY APPLIES TO THE REQUEST FOR A NEW STERILIZATION SITE
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