SELUTE LEADS AND ACCESSORIES
FDA premarket approval P950001/S009 · decided 2002-12-13
Approval details
- PMA number
- P950001
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SELUTE LEADS AND ACCESSORIES
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2002-11-13
- Decision date
- 2002-12-13
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE IN THE MANUFACTURING PROCESS TO THE PARAMETRIC RELEASE METHOD, WHICH INVOLVES STERILE PRODUCT RELEASE BASED ON CONFORMANCE TO PRE-DEFINED STERILIZATION PARAMETERS RATHER THAN A RELEASE BASED ON DEMONSTRATING NO GROWTH IN BIOLOGICAL INDICATOR.
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