TELIGEN FAMILY
FDA premarket approval P960040/S200 · decided 2009-06-26
Approval details
- PMA number
- P960040
- Supplement
- S200
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- TELIGEN FAMILY
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2009-05-27
- Decision date
- 2009-06-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGES TO: 1) MOVE THE FABRICATION OF THE L-TAB FROM AN OUTSIDE VENDOR TO IN-HOUSE; 2) ETCH THE TAB INSTEAD OF STAMPING IT; 3) ADD AN ALUMINUM SHEET METAL CONTRACTOR; AND 4) REVISE TWO DIMENSIONS OF THE TAB.
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