FINELINE II/THINLINE II
FDA premarket approval P960040/S163 · decided 2008-04-02
Approval details
- PMA number
- P960040
- Supplement
- S163
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FINELINE II/THINLINE II
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2008-03-03
- Decision date
- 2008-04-02
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADDITION OF TWO NEW SUPPLIERS FOR MATERIALS.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.