SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
FDA premarket approval P950001/S002 · decided 1997-09-19
Approval details
- PMA number
- P950001
- Supplement
- S002
- 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
- 1997-04-03
- Decision date
- 1997-09-19
- Days to decision
- 169 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a manufacturing site lcoated at Cardiac pacemakers, Inc., Del Caribe, Road 698 Lot No. 12, Dorado, PR 00646.
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