Myopore Sutureless Myocardial Pacing Lead
FDA premarket approval P130012/S003 · decided 2017-06-08
Approval details
- PMA number
- P130012
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Myopore Sutureless Myocardial Pacing Lead
- Generic name
- permanent pacemaker Electrode
- Applicant
- Great Batch Medical
- Date received
- 2017-05-12
- Decision date
- 2017-06-08
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- DTB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for the addition of a 100% in-line inspection for gel lumps in the body tubing of the Myopore lead.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| RadialSeal Introducer Kit (K181855) | Great Batch Medical | 2018-07-26 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH (K130559) | Great Batch Medical | 2013-05-24 |
| MOBICATH TRANSSEPTAL NEEDLE (K122832) | Great Batch Medical | 2012-12-19 |
| Z FLEX-270TM STEERABLE SHEATH (K112541) | Great Batch Medical | 2012-02-07 |
| RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT (K110051) | Great Batch Medical | 2012-02-02 |
| MOBICATH TRANSSEPTAL NEEDLE (K111644) | Great Batch Medical | 2011-10-03 |
| MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX (K101784) | Great Batch Medical | 2010-11-26 |
| PTFE PORTABLE INTRODUCER (K102540) | Great Batch Medical | 2010-11-16 |