FLEXTEND LEADS, MODELS 4086, 4087, AND 4088
FDA premarket approval P960006/S015 · decided 2005-05-06
Approval details
- PMA number
- P960006
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FLEXTEND LEADS, MODELS 4086, 4087, AND 4088
- Generic name
- permanent pacemaker Electrode
- Applicant
- Boston Scientific
- Date received
- 2005-04-13
- Decision date
- 2005-05-06
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- CHANGE OF SILICONE ADHESIVE.
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