FINELINE FAMILY INCLUDES FINELINE, FINELINE II
FDA premarket approval P960004/S028 · decided 2005-03-24
Approval details
- PMA number
- P960004
- Supplement
- S028
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE FAMILY INCLUDES FINELINE, FINELINE II
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2005-02-24
- Decision date
- 2005-03-24
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE TO THE PROCEDURE FOR INSPECTIONS OF LEADS WITH DRUG SUBASSEMBLIES.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.