PMA P950001S002
- Device
- SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S002
- Product code
- DTB
- Decision date
- 1997-09-19
- Generic name
- permanent pacemaker Electrode
- Approval order statement
- Approval for a manufacturing site lcoated at Cardiac pacemakers, Inc., Del Caribe, Road 698 Lot No. 12, Dorado, PR 00646.
Current openFDA PMA Record#
- Device
- SELUTE STEROID ELUTING ENDOCARDIAL LEAD MODELS 4185 & 4285
- Applicant
- Boston Scientific
- PMA number
- P950001
- Supplement
- S002
- Product code
- DTB
- Generic name
- permanent pacemaker Electrode
- Decision date
- 1997-09-19
- Decision code
- APPR
- Date received
- 1997-04-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site lcoated at Cardiac pacemakers, Inc., Del Caribe, Road 698 Lot No. 12, Dorado, PR 00646.